Jazz System
93 catalogue numbers from Jazz Screw - Polyaxial Screw Dia.7.5 L50, listed by Implanet, France, under Thoracolumbosacral Pedicle Screw System. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
93catalogue numbers in this listing
2510(k) clearances naming this product code
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) | K182771 |
| Record published | 2019-03-20 |
| Record revised | 2025-07-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 30 to 400 mm; lumen/inner diameter 5 to 8 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Jazz Screw – Polyaxial Screw Dia.7.5 L50 | Lumen/Inner Diameter 7.5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7.5 L60 | Lumen/Inner Diameter 7.5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6 L45 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Rod – Straight Union Rod → L160 | Length 160 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7.5 L35 | Lumen/Inner Diameter 7.5 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod Dia.6.0 L70 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod Dia.6.0 L60 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6 L55 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.5 L40 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.6 L60 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.5 L35 | Length 35 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod → L50 | Length 50 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7.5 L55 | Lumen/Inner Diameter 7.5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7 L60 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod → L100 | Length 100 mm | In distribution |
| JAZZ Cap SP, H12 | In distribution | |
| Jazz Rod – Pre-bent Union Rod Dia.6.0 L100 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5.5 L40 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6.5 L60 | Lumen/Inner Diameter 6.5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7.5 L40 | Lumen/Inner Diameter 7.5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5.5 L60 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod Dia.6.0 L80 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Rod – Straight Union Rod Dia.6.0 L400 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5 L60 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5.5 L50 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.7 L60 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Rod – Straight Union Rod → L110 | Length 110 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod → L90 | Length 90 mm | In distribution |
| Jazz Rod – Straight Union Rod → L120 | Length 120 mm | In distribution |
| Cap SP anti-torque wrench | In distribution | |
| Jazz Screw – Monoaxial Screw Dia.7 L45 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.6 L35 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5.5 L55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod → L70 | Length 70 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod Dia.6.0 L40 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6.5 L40 | Lumen/Inner Diameter 6.5 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.7 L35 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.7 L50 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7.5 L45 | Lumen/Inner Diameter 7.5 mm | In distribution |
| JAZZ Screw – Polyaxial Screw Dia.5 L35 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6 L60 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7 L35 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6 L50 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5.5 L35 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6.5 L35 | Lumen/Inner Diameter 6.5 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.5 L55 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod Dia.6.0 L30 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6 L40 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.8 L55 | Lumen/Inner Diameter 8 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.6 L50 | Lumen/Inner Diameter 6 mm | In distribution |
| JAZZ Cap SP, H14 | In distribution | |
| Hexagonal 3,5 Evo Screwdriver | In distribution | |
| Jazz Screw – Polyaxial Screw Dia.6 L35 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.8 L60 | Lumen/Inner Diameter 8 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.6 L40 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7 L50 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5 L55 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Rod – Straight Union Rod → L300 | Length 300 mm | In distribution |
| Jazz Rod – Straight Union Rod Dia.6.0 L160 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5 L45 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7 L55 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.7 L55 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6.5 L50 | Lumen/Inner Diameter 6.5 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6.5 L45 | Lumen/Inner Diameter 6.5 mm | In distribution |
| Jazz Rod – Straight Union Rod → L200 | Length 200 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5 L50 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.5 L45 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod Dia.6.0 L90 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.6.5 L55 | Lumen/Inner Diameter 6.5 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.6 L55 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.8 L45 | Lumen/Inner Diameter 8 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.8 L40 | Lumen/Inner Diameter 8 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod → L60 | In distribution | |
| Jazz Rod – Straight Union Rod Dia.6.0 L120 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod Dia.6.0 L50 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5.5 L45 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod → L30 | Length 30 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod → L40 | Length 40 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.5 L60 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.7 L40 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Rod – Pre-bent Union Rod → L80 | Length 80 mm | In distribution |
| Jazz Rod – Straight Union Rod → L400 | Length 400 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.8 L35 | Lumen/Inner Diameter 8 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.5 L50 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Rod – Straight Union Rod Dia.6.0 L300 | Lumen/Inner Diameter 6 mm | In distribution |
| JAZZ Cap SP, H10 | In distribution | |
| Jazz Screw – Monoaxial Screw Dia.8 L50 | Lumen/Inner Diameter 8 mm | In distribution |
| Jazz Rod – Straight Union Rod Dia.6.0 L110 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7 L45 | Lumen/Inner Diameter 7 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.5 L40 | Lumen/Inner Diameter 5 mm | In distribution |
| Jazz Rod – Straight Union Rod Dia.6.0 L200 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Monoaxial Screw Dia.6 L45 | Lumen/Inner Diameter 6 mm | In distribution |
| Jazz Screw – Polyaxial Screw Dia.7 L40 | Lumen/Inner Diameter 7 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 |
|---|---|
| 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.