VersaLink™ Fixation System
The VersaLink rod is a titanium alloy spinal fixation component with a ring end that attaches to a pedicle screw head above a crossbar. A dedicated ring nut and double-threaded ring set…
The VersaLink rod is a titanium alloy spinal fixation component with a ring end that attaches to a pedicle screw head above a crossbar. A dedicated ring nut and double-threaded ring set screw secure this connection. It is part of the VersaLink fixation construct.
The system also includes a bent crossbar rod, polyaxial pedicle screws and Torx set screws. The crossbar connects two pedicle screws in the same vertebra. Together these components immobilize and stabilize spinal segments as an adjunct to fusion in skeletally mature patients.
Listed Item
VersaLink Rod Posterior Offset, 0°, 45 mm The VersaLinkTM Fixation System is a titanium fusion construct that is designed to connect proximally or distally to a fusion crossbar. The VersaLink Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
Spinal Indications and Approach
System indications cover thoracic, lumbar and sacral instability or deformity associated with degenerative disc disease, spondylolisthesis, trauma, stenosis, spinal curvature, tumor, pseudoarthrosis or failed fusion. Implantation can use an open approach or a posterior percutaneous approach with minimally invasive instrumentation.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Premia Spine Ltd., Israel |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K182598 |
| Record published | 2024-02-14 |
| Record revised | 2024-09-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 40 to 120 mm; angle 0 to 30 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 82876 | Length 40 mm | In distribution |
| 82565 | Length 90 mm | In distribution |
| 87180 | Length 75 mm | In distribution |
| 87555 | Length 65 mm | In distribution |
| 82570 | Length 55 mm | In distribution |
| 87556 | Length 70 mm | In distribution |
| 87533 | Length 85 mm | In distribution |
| 87179 | Length 70 mm | In distribution |
| 82567 | Length 55 mm | In distribution |
| 82572 | Length 50 mm | In distribution |
| 86277 | Length 70 mm | In distribution |
| 82574 | Length 60 mm | In distribution |
| 87549 | Length 70 mm | In distribution |
| 82566 | Length 50 mm | In distribution |
| 87534 | Length 45 mm | In distribution |
| 87548 | Length 65 mm | In distribution |
| 87178 | Length 65 mm | In distribution |
| 87554 | Length 45 mm | In distribution |
| 87565 | Length 80 mm | In distribution |
| 87523 | Length 85 mm | In distribution |
| 82666 | Length 60 mm | In distribution |
| 87537 | Length 75 mm | In distribution |
| 82569 | Length 50 mm | In distribution |
| 87563 | Length 70 mm | In distribution |
| 87528 | Length 85 mm | In distribution |
| 82575 | Length 50 mm | In distribution |
| 86164 | Length 70 mm | In distribution |
| 87538 | Length 80 mm | In distribution |
| 82576 | Length 55 mm | In distribution |
| 87541 | Length 65 mm | In distribution |
| 87520 | Length 45 mm | In distribution |
| 87532 | Length 75 mm | In distribution |
| 87559 | Length 85 mm | In distribution |
| 82880 | Length 50 mm | In distribution |
| 82562 | Length 50 mm | In distribution |
| 82571 | Length 60 mm | In distribution |
| 87551 | Length 80 mm | In distribution |
| 87980 | Length 120 mm | In distribution |
| 87521 | Length 65 mm | In distribution |
| 87526 | Length 65 mm | In distribution |
| 82621 | Length 45 mm | In distribution |
| 82879 | Length 40 mm | In distribution |
| 87557 | Length 75 mm | In distribution |
| 87531 | Length 65 mm | In distribution |
| 82884 | Length 40 mm | In distribution |
| 86276 | Length 60 mm | In distribution |
| 86278 | Length 80 mm | In distribution |
| 87525 | Length 55 mm | In distribution |
| 87564 | Length 75 mm | In distribution |
| 87542 | Length 70 mm | In distribution |
| 87561 | Angle 30 ° | In distribution |
| 86165 | Length 80 mm | In distribution |
| 87979 | Length 120 mm | In distribution |
| 82873 | Length 40 mm | In distribution |
| 87530 | Length 55 mm | In distribution |
| 82577 | Length 60 mm | In distribution |
| 87182 | Length 85 mm | In distribution |
| 87536 | Length 70 mm | In distribution |
| 87181 | Length 80 mm | In distribution |
| 87562 | Length 65 mm | In distribution |
| 82875 | Length 40 mm | In distribution |
| 82883 | Length 40 mm | In distribution |
| 87547 | Length 45 mm | In distribution |
| 87529 | Length 45 mm | In distribution |
| 87567 | Length 90 mm | In distribution |
| 82578 | Length 50 mm | In distribution |
| 87539 | Length 85 mm | In distribution |
| 87545 | Length 85 mm | In distribution |
| 86161 | Length 70 mm | In distribution |
| 82882 | Length 40 mm | In distribution |
| 82878 | Length 50 mm | In distribution |
| 87544 | Length 80 mm | In distribution |
| 86279 | Length 90 mm | In distribution |
| 82568 | Length 60 mm | In distribution |
| 82874 | Length 45 mm | In distribution |
| 87981 | Length 120 mm | In distribution |
| 87535 | Length 65 mm | In distribution |
| 82877 | Length 40 mm | In distribution |
| 87560 | Length 90 mm | In distribution |
| 82881 | Length 90 mm | In distribution |
| 87177 | Length 45 mm | In distribution |
| 82564 | Length 60 mm | In distribution |
| 82573 | Length 55 mm | In distribution |
| 87527 | Length 75 mm | In distribution |
| 87522 | Angle 0 ° | In distribution |
| 87553 | Length 90 mm | In distribution |
| 87540 | Length 45 mm | In distribution |
| 87566 | Length 85 mm | In distribution |
| 87546 | Angle 15 ° | In distribution |
| 87552 | Length 85 mm | In distribution |
| 87550 | Length 75 mm | In distribution |
| 82563 | Length 55 mm | In distribution |
| 87543 | Length 75 mm | In distribution |
| 82620 | Length 50 mm | In distribution |
| 82581 | Length 90 mm | In distribution |
| 82579 | Length 55 mm | In distribution |
| 86166 | Length 90 mm | In distribution |
| 82580 | Length 60 mm | In distribution |
| 87524 | Length 45 mm | In distribution |
| 86163 | Length 60 mm | In distribution |
| 86162 | Length 80 mm | In distribution |
| 87558 | Length 80 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232719 | 2023-11-21 |
| K231844 | 2023-07-07 |
| K182598 | 2018-11-13 |
| K170061 | 2017-02-02 |
| K150380 | 2015-07-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.