Jazz Spinal System
Jazz Spinal System stabilizes noncervical spinal segments through a posterior screw-and-rod construct. Components lock together in configurations selected for the individual anatomy and…
Jazz Spinal System stabilizes noncervical spinal segments through a posterior screw-and-rod construct. Components lock together in configurations selected for the individual anatomy and fusion procedure.
The implant family uses titanium alloy and cobalt-chromium alloy. It includes straight and prebent rods, monoaxial and polyaxial screws, reduction screws and connecting components.
Listed Item
Cannulated Polyaxial reduction screw 5.5×40
Construct Options
Cannulated and noncannulated screw versions are available, along with uniplanar, modular, favored-angle and S2AI options. Domino, lateral and crosslink connectors join parts of the construct. The listed family includes a cannulated polyaxial reduction screw; the complete system provides mechanical immobilization as an adjunct to fusion.
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 | Implanet, France |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K240392 |
| Record published | 2025-06-27 |
| Record revised | 2025-10-28 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 633600 | In distribution | |
| 631065 | In distribution | |
| 633603 | In distribution | |
| 633601 | In distribution | |
| 634828 | In distribution | |
| 631063 | In distribution | |
| 631066 | In distribution | |
| 633613 | In distribution | |
| 634364 | In distribution | |
| 631056 | In distribution | |
| 633612 | In distribution | |
| 634458 | In distribution | |
| 634365 | In distribution | |
| 634362 | In distribution | |
| 631054 | In distribution | |
| 635395 | In distribution | |
| 635392 | In distribution | |
| 631702 | In distribution | |
| 634366 | In distribution | |
| 631339 | In distribution | |
| 633592 | In distribution | |
| 634457 | In distribution | |
| 635393 | In distribution | |
| 635396 | In distribution | |
| 634378 | In distribution | |
| 633614 | In distribution | |
| 633611 | In distribution | |
| 634377 | In distribution | |
| 633599 | In distribution | |
| 631337 | In distribution | |
| 631343 | In distribution | |
| 633602 | In distribution | |
| 634456 | In distribution | |
| 631052 | In distribution | |
| 634461 | In distribution | |
| 631335 | In distribution | |
| 631341 | In distribution | |
| 634852 | In distribution | |
| 633593 | In distribution | |
| 633591 | In distribution | |
| 631347 | In distribution | |
| 634376 | In distribution | |
| 631077 | In distribution | |
| 631049 | In distribution | |
| 631344 | In distribution | |
| 634363 | In distribution | |
| 631051 | In distribution | |
| 634375 | In distribution | |
| 634462 | In distribution | |
| 631058 | In distribution | |
| 631055 | In distribution | |
| 631342 | In distribution | |
| 631050 | In distribution | |
| 635363 | In distribution | |
| 635394 | In distribution | |
| 634041 | In distribution | |
| 634374 | In distribution | |
| 634851 | In distribution | |
| 631352 | 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 |
|---|---|
| K252437 | 2025-08-28 |
| K240392 | 2024-05-06 |
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.