Package No. 1 - Cervical vertebral prosthesis, PEEK.

Package No. 2 - Consumables providing the possibility of performing endoscopic procedures.

Package No. 3 - Core stimulator 16-contact, constant voltage.

Package No. 4 – Set for spinal cord stimulation, trial and final, constant intensity.

Package No. 5 - Pulse generator for spinal cord stimulation rechargeable, constant current.

Package No. 6 - Non-rechargeable spinal cord stimulator.

Package No. 7 - Spinal cord stimulator rechargeable.

Package No. 8 - Set for transepiphyseal stabilization of the spine Th/L.

Package No. 9 - TLIF interbody implants.

Package No. 10 - Expandable PLIF/TLIF interbody cages.

Package No. 11 - Titanium system for single- and multi-segment posterior stabilization of the cervical spine and occipital-cervical stabilization of the spine.

Package No. 12 - Lumbar implant for lumbar stabilization from the lateral side of the spine, ALIF interbody implant.

lp. product name one measure quantity for 24 months price one. net single price gross net value gross value trade name/manufacturer/part number List all the elements that are part of the set and indicate the net price of each

1 Cervical body prosthesis, PEEK pcs 20

sum

Technical description:

- implant made of PEEK does not require pre-assembly, sterile

- implant without metal elements that prevent CT, MRI tests

- in the implant, titanium radiological markers facilitating the assessment of the position of the cage in the interbody space and the assessment of the degree of distraction

- implant height 17-70 mm

- possibility of replacing one, two/three adjacent vertebral bodies

- the possibility of expanding the implant structure "in situ"

- implant lock made of PEEK

- implant boundary plates with a serrated surface to prevent migration

- possibility of repetitive/controlled adjustment of the implant height with a locking mechanism

- implants with permanent markings

- instruments in a container intended for storage and sterilization

lp. product name one measure quantity for 24 months price one. net single price gross net value gross value trade name/manufacturer/

part number List all the elements that are included in the set and indicate the net price of each

Expandable PLIF/TLIF interbody cage pcs 60

sum

Technical description:

- minimal implant entry window, allowing for greater security of access;

- Controlled and smooth expansion range of the implant in the final position;

- automatic bolocation of the optimal height;

- the possibility of filling the implant with a bone graft in its final setting and height;

- 3 shape variants: flat, lordotic and hyperlordotic

- sizes: 6.5, 8.5, 10.5, 12.5 mm,

- width 10 mm,

- length: 24 mm and 28 mm,

- max. lordosis : - flat implants 0-5 degrees, lordotic implants 7 - 12 degrees, hyperlordotic implants 15 -23 degrees

Titanium system for single- and multi-segment posterior cervical stabilization and occipital-cervical stabilization of the spine.

lp. product name one measure quantity for 24 months price one. net single price gross net value gross value trade name/manufacturer/

part number List all the elements that are included in the set and indicate the net price of each

1. titanium system for single- and multi-segment posterior cervical stabilization and occipital-cervical stabilization of the spine, based on the possibility of using hooks, multi-axis screws and occipital plates four- and five-hole occipital plates, small and large; screws for occipital plates (Ø4.5 and 5.5mm, length 6-16mm, with 1mm increments); straight rods diam. 3.5mm, length 30-150mm (atraumatic, with 30mm increments); bent bars ø3,5mm, length 240mm, atraumatic; connecting rods to the thoracolumbar system with a double diameter of Ø3.5-5.5mm; Multi-axis screws Ø3,5 and 4,0mm, length 10-30mm, with 2mm increments; Multi-axis screws Ø4,0mm, length 10-56mm, with 2mm increments, with an increased bending angle of 45 degrees; multi-axis screws for stabilization C1-C2 - ø4,0mm with smooth shank length 8-16mm and length. thread 16-26mm (in 2mm increments); atraumatic termination of screws; laminar hooks large and small, left and right; one internal locking element for screws, hooks, fasteners and occipital plates; Rigid crossbars by length. 22-24-26mm and with variable shape (28-33mm, 33-42mm and 42-58mm) with the possibility of laying crossbars polygonally in the stand of the member and the axis of the glazing; straight or L-bent right and left side connectors (7, 9 and 11mm); parallel bar connectors (Ø3.5-3.5mm and Ø3.5-5.5mm); left and right (450) and straight (90) cable holders; all color-coded implants; application of the system for various types of treatments – using one set of tools with the possibility of intraoperative selection of all implanes; permanent marking of each implant with a batch number and code; flexible measures of the shape of rods (length 60, 120 and 290mm); torque wrenches for tightening occipital screws, nuts; plastic, resealable container for all types of implants; handy, ergonomic and limited to the necessary minimum instrumentarium in sealable cassettes; set 5

2. Occiput plate pcs 4

3. Screw for occiput pcs 20

4. Screw/hook pcs 60

5. Blocker pcs 60

6. Rod pcs 30

sum

Technical description:

- titanium system for single- and multi-segment posterior stabilization of the cervical spine and occipital-cervical stabilization of the spine, based on the possibility of stagging hooks, multiaxial screws and occipital plates

- occipital plates four- and five-hole, small and large;

- straight rods dia. 3.5mm, length 30-150mm (atraumatic, with 30mm increments);

- bent bars ø3.5mm, length. 240mm, atraumatic;

- connecting rods with a thoracolumbar system with a double diameter of ø3.5-5.5mm;

- multi-axis screws ø3.5 and 4.0mm, length. 10-30mm, with 2mm increments;

- multi-axis screws ø4.0mm, length 10-56mm, with 2mm increments, with an increased bending angle of 45 degrees;

- multi-axis screws for stabilization C1-C2 - ø4.0mm with a smooth shaft with a length. 8-16mm and length thread 16-26mm (with 2mm increments);

- atraumatic end of the screws;

- laminar hooks large and small, left and right;

- one internal locking element for screws, hooks, fasteners and po-tylicz plates;

- rigid crossbars by length. 22-24-26mm and variable shape (28-33mm, 33-42mm and 42-58mm) with the possibility of polygon stacking crossbars in the bar and the axis of the glazing;

- straight or L-bent side connectors right and left (7, 9 and 11mm);

- parallel bar connectors (ø3.5-3.5mm and ø3.5-5.5mm);

- cable holders left and right (450) and straight (90);

- all color-coded implants;

- application of the system for various types of treatments – using one set of tools with the possibility of intraoperative selection of all implants;

- permanent marking of each implant with a batch number and code;

.................................. Further description in SWZ....................

Part 1 - Lumbar implant to stabilize the lumbar spine from the lateral side of the spine.

lp. product name one measure quantity for 24 months price one. net single price gross net value gross value trade name/manufacturer/

part number List all the elements that are included in the set and indicate the net price of each

1. Lumbar implant to stabilize the lumbar spine from the lateral side of the spine. set 60

sum

LLIF – interbody, blocked lumbar implant for segment stabilization

lumbar from the lateral side of the spine. The lumbar chest has three

lordosis angles (4֯, 8֯ and 12֯). Dimensions: standard size: 20 x 35-60 mm.

Height 8- 18 mm. The implant is made in 3D printing technology in its entirety

Titanium cell 80% porous, pore size 750 um. Solid cage-

no need to fill with bone substitute, without central opening

for filling. Fastened to the shafts with 2 screws locked in the cage behind

by means of a self-locking ratchet mechanism to prevent

migration of screws, screw heads after locking do not increase the profile of the cage, are

equated with the locking mechanism. Self-tapping screws made of

titanium alloy with a diameter of 6.0 mm and lengths in the range of 25mm-60mm

with 5mm graduation. A set of instruments for implantation in a sterilization container

Implanes marked, supplied in a sterile package containing a code, serial number and expiry date

Part 2 - ALIF interbody implant

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part number List all the elements that are included in the set and indicate the net price of each

1. Implant międzytrzonowy ALIF kpl 20

Sum:

Technical description:

ALIF – interbody, blocked lumbar implant for segment stabilization

lumbar from the side of the anterior column of the spine. Lumbar chest

It has three angles of lordosis (8֯, 12֯ and 18֯). Dimensions: standard size: 36 x 29

mm, small: 32x 24 mm. Height 8- 18 mm. The implant is made in

3D printing technology made entirely of cellular titanium 80% porous,

Pore size 750 um. Solid cage – no need to fill

bone substitute, without a central opening for filling. Fastened

up to the shafts with 2 screws locked in the cage by means of self-locking

ratchet mechanism to prevent the migration of screws, screw heads after

locking does not increase the profile of the frame, they are equated with the mechanism

Blocking. Self-tapping screws made of titanium alloy with

diameter 5.5 mm and lengths in the range of 20mm- 50mm with gradation every

5mm. A set of instruments for implantation in a sterilization container.

Implant labelled, supplied in a sterile package containing

code, serial number and expiry date.

Consumables for endoscopic procedures.

l.p Detailed description quantity per 24 months Net price Net value Net rate Vat value Gross value Number of pcs. In op.handl. Trade name/manufacturer/

part number List all the elements that are included in the set and indicate the net price of each

1. Radioablation electrode - short 50 pcs 1

2. Radioablation electrode – long 30 pcs 1

3. Access cannula – short dia.1.25mm 5 op. 10

4. Access cannula – long dia.1.5mm 5 op. 10

5. Set of disposable irrigation drains, sterile with punches, RFID identification with pump for endoscopic spine surgery owned by the customer. 50 pcs 10

7. Reusable oval blade with side guard dia. 4 mm, working length 350 mm 1 pc. 1

8. Reusable ball blade dia. 4 mm, working length 350 mm 1 pc. 1

9. Reusable diamond blade dia. 4 mm, working length 350 mm 1 pc. 1

TOGETHER:

Technical description:

- Electrodes, cannulas and drains compatible with the RF RIWO Spine generator and the Vertebris Lumbar RIWO Spine endoscopic spine surgery system

- The ordering party requires regular training of medical personnel in the aspect of surgical techniques of endoscopic spine surgery.

Core stimulator, 16-contact, constant voltage

l.p Product name quantity per 24 months PLN Net price PLN Net value PLN VAT rate Vat value Gross price PLN Gross value PLN Number of pcs. In op.handl. Trade name/manufacturer/

part number List all the elements that are included in the set and indicate the net price of each

1. Spinal cord pacemaker, sixteen-contact

Surgical electrode or two transdermal electrodes

Two electrode connectors Patient programmer Screening cable 4 op. 1

SUM:

Technical description:

· constant current voltage

· amplitude from 0 to 10.5 V

· Pulse duration from 60 to 450 μs

· frequency from 2 to 130 Hz

· possibility of using transcutaneous or surgical electrodes

· sixteen-contact electrodes, electrode wire length in the range of 30-75 cm

· length of fasteners to choose from in the range of 20-60 cm

The Contracting Authority requires the use of a therapy programmer and an external stimulator for the duration of the contract. In addition, regular training of medical staff in the implantation and conduct of therapies resulting from the obligation to continue education and the implementation of new technologies.

L.p. Product name quantity per 24 months Price unit. Net Net value VAT rate Including VAT Price unit. Gross Gross Value Number of pcs. In op.handl. Trade name/manufacturer/

part number List all the elements that are included in the set and indicate the net price of each

1. Non-rechargeable pulse generator 2channel 10 pcs 1

2. 20 contact surgical electrode 4 pcs 1

3. Electrode 8 contact transdermal or intermediate-flat or insertion system to intermediate electrode 20 pcs 1

4. Patient programmer 20 pcs 1

5. Electrode compatible adapter or adapter for electrodes from other manufacturers 10 pcs 1

6. Test stimulator head 20 pcs 1

7. Intraoperative stimulation cable 20 pcs 1

8. Tunnelizer 10 pcs 1

TOGETHER:

Technical description:

· non-rechargeable two-channel generator with a capacity of 5.3 Ahr or 7.5Ahr to choose from

by the ordering party

· constant amperage that guarantees a constant level of stimulation regardless of

resistance changes.

· possibility of using tonic stimulation and BURST DR stimulation in one device with confirmed

efficacy in clinical trials.

· stimulator with a head compatible with St Jude Medical and Medtronic electrodes for

Check.

· possibility of performing MRI of the whole body 1.5T

· 20-contact electrode - 5 columns, 4 rows

· transdermal electrode 8 contact or intermediate flat 8 contact with the system

for entering

· length of connectors to choose from: 30 and 60 cm

· electrode wire length 60 cm

· Test stimulation system - wireless.

· Patient programmer in Polish - enabling wireless operation of the device using

Bluetooth connections

· adapters compatible with electrodes of others

Producers

The Contracting Authority requires regular training of medical personnel in the implantation aspect and the conduct of therapies resulting from the obligation to continue to educate and implement new technologies.

L.p. Product name quantity per 24 months Price unit. Net Net value VAT rate Including VAT Price unit. Gross Gross Value Number of pcs. In op.handl. Trade name/manufacturer/

part number List all the elements that are included in the set and indicate the net price of each

1. Pulse generator rechargeable 2channel 1 op 1

2. Patient programmer 1 op 1

3. Ładowarka 1 on 1

Together

Technical description:

· 2-channel rechargeable generator

· Constant amperage, which guarantees a constant level of stimulation regardless of resistance changes.

· possibility of using tonic stimulation and BURST DR stimulation in one device with proven effectiveness in clinical trials.

· stimulator compatible with Abbott Medical electrodes

The Contracting Authority requires regular training of medical personnel in the implantation aspect and the conduct of therapies resulting from the obligation to continue to educate and implement new technologies.

L.p. Product name quantity per 24 months Price unit. Net PLN Net value VAT rate Including VAT Price unit. Gross Gross Value Number of pcs. In op.handl. Trade name/manufacturer/

part number List all the elements that are included in the set and indicate the net price of each

1. Non-rechargeable pulse stimulator for spinal cord stimulation 6 op. 1

2. Wireless patient remote control with Bluetooth 6 op. 1

3. Surgical electrode with 16 independent contacts 50 or 70 cm long, 1 op. selectable 1

4. Fissure verifier after laminectomy 2 op. 1

5. Transdermal electrode with 8 3mm contacts and 1mm or 4mm or 6mm spacing and total electrode length 50 or 70cm, 5 op. selectable 1

6. 8-contact electrode connector compatible with transdermal and surgical electrodes 25, 35 or 55cm in length, 10 op. selectable. 1

7. Tunelizator 28cm 6 op. 1

8. External test cable 2-input, 16-link, length 60cm 6 pcs. 1

9. Set of patient test accessories 6 op. 1

10. Mechanical anchor 4 cm long (2 pcs) 7 pcs. 2

TOGETHER:

Technical description:

•16 contact pacemaker

•Constant amperage

•Independent control of each contact from 0 to 100%, incremental by 1% (MICC)

•Amplitude from 0 to 25.5 mA

•Frequency from 2 to 1,200 Hz

•Pulse duration from 20 to 1,000 μs

•Transcutaneous or surgical electrodes can be used

•Volume: 34.9cc

•Size: 70.9mm x49.5mm x 11.6mm

•Implantation depth of pacemaker max 2.5cm

•Burst, High Frequency, Tonic, Contour and FAST stimulation available

•Connect the electrode directly to the pacemaker or via a connector

•Battery capacity 7Ahr

•Compatible with 1.5T MRI

•Bluetooth

•Lending the evaporating magnet to the patient controller and the clinician's programmer - 2 pcs

•Lending an external stimulator, enabling independent control over at least 30 contacts - 2 pcs; service of the subject of the loan during the period of putting into use

•Lending the clinician's programmer - 1 set.; Service of the object of lending during the period of putting into use

The Contracting Authority requires regular training of medical personnel in the implantation aspect and the conduct of therapies resulting from the obligation to continue to educate and implement new technologies.

L.p. Product name quantity per 24 months Price unit. Net PLN Net value VAT rate Including VAT Price unit. Gross Gross Value Number of pcs. In op.handl. Trade name/manufacturer/

part number List all the elements that are included in the set and indicate the net price of each

1. Rechargeable pulse stimulator for spinal cord stimulation 1 op. 1

2. Wireless stimulator charger with mains adapter 1 op. 1

TOGETHER:

Technical description:

•16 contact pacemaker.

•Constant amperage.

•Battery for 12 years.

•Independent control of each contact from 0 to 100%, incremental by 1% (MICC)

•Illuminates 3D

•Amplitude from 0 to 25.5 mA

•Frequency from 2 to 1,200 Hz

•Pulse duration from 20 to 1,000 μs

•Transcutaneous or surgical electrodes can be used

•Volume 20.1cc

•Size: 52.1mm x46mm x 10.7mm

•Implantation depth of pacemaker max 2.5cm

•Burst, High Frequency, Tonic, Contour and FAST stimulation available

•Connect the electrode directly to the pacemaker or via a connector

•Compatible with 1.5T MRI

•Bluetooth

•Adapters compatible with previously implantable third-party pacemakers

•Patient pilot included in the price of the kit

The Contracting Authority requires regular training of medical personnel in the implantation aspect and the conduct of therapies resulting from the obligation to continue to educate and implement new technologies.

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part number List all the elements that are included in the set and indicate the net price of each

1. Screws pcs. 400

2. Blockers pcs. 400

3. Rods pcs. 20

4. Crossbars pcs. 10

sum

Technical description:

Screws with a pentagonal shaft and double threaded along the entire length, tulip cannulated rigid and movable,

cannulated and augumentation. Color-coded screws to correctly identify the size. Solo and self-tapping screws with atraumatic ending, sterile and non-sterile. The ability to lock the polyaxiality of screws at any time without blocking the possibility of moving the rod relative to the screw. Full and cannulated movable screws of the following sizes:

f4.5mm and f5.5mm with length. 25 50mm, in 5mm increments;

f6,5mm with a length 25 55mm, with 5mm increments; and 60 80mm length with 10 mm increments

f7,5mm with length 25 55mm, with 5mm increments and 60 110 with 1 0 mm increments

f8,5mm with length 30 55mm, with 5mm increments; and 60 110 with 10 mm increments

f9,5mm with a length 35 55mm, with 5mm increments and 60 110 with 10mm increments

f10,5mm with length 35 55mm, with 5mm increments and 60 110 with 10mm increments

Augumentation and movable screws of the following sizes:

f5,5mm with a length 35 50mm, with 5mm increments;

f6,5mm with a length 35 55mm, with 5mm increments; and 60 80mm length with 10 mm increments

f7,5mm with length 35 55mm, with 5mm increments and 60 80mm in increments

f8,5m m o lw. 35 55mm, with 5mm increments and 60 80mm in increments

f9,5mm with a length 35 55mm, with 5mm increments and 60 80mm in increments

f10,5mm with length 35 55mm, with 5mm increments and 60 80mm in increments

1) straight bars with hexagonal and round ends f5.5mm, 24 different sizes of length from 30 to 500mm. From 35mm to 55 mm travel every 5mm and from 60mm to 200mm every 10 mm and from 200mm to 500 mm every 100 mm. Rods available in sterile and non-sterile versions.

2) the bars will pre-bend those with hexagonal and round endings f5.5mm, length. 35 150mm, in 16 sizes.

Lending for the duration of the contract a set of 2 sets of soft tissue dilators with a replaceable muscle expansion spatula with a ball latch.

Blade sizes from 3 5 mm to 70 mm.

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part number List all the elements that are included in the set and indicate the net price of each

1. Interbody implants

TLIF pcs. 50

sum

Technical description:

made of PEEK sprayed with pure titanium, translucent, serrated implants for intervertebral stabilization of the posterior lumbar spine (TLIF/PLIF) with

the shape of bent blocks;

implants in 30 sizes: height 7 17mm with 1mm increments), length. 26mm and 30mm and 34mm and 11.5mm wide;

the possibility of placing the implant on the left or right side or. spine axis;

the large surface area allows for maximum contact with the bone and a radical reduction in loads on the surface of the vertebrae;

the opening inside the implant allows the placement of bone chips, synthetic material or overgrowth with bone tissue;

three tantalum X-ray markers, enabling postoperative location of the implant;

primary stabilization press fit increasing the stability of the implant and the serrated contact surface with the vertebrae;

permanent marking of each implant with a batch number and code;

each implant separately, sterilely packed;

flattened nose facilitating the introduction of the implant into space

articulated implant insertion tool (inserter)

porosity of the surface of the implant sprayed with pure titanium reaching 60%

the possibility of rotation of the implant in situ by 90°C in relation to the axis of the implant insertion tool (I nserter) and the type of implant without the axis of rotation relative to the insertion tool

instruments placed in marked places in lockable sterilization containers;

handy, ergonomic and limited to the necessary minimum instrumentarium, including, m.in. distractors in 10 sizes, retractors in 4 sizes, test measures for each implant size, tools for selecting material from the L/R side, tool for implant placement from the L/R side and a pad for filling the inner hole

Maintenance-free sterilization container with a lid that allows 5000 sterilization cycles without the need to change filters.