Polaris 6.35 SST Spinal System
21 catalogue numbers from 14-577440, listed by Biomet Spine, United States, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-02 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-577440 | 6.5MM(D) X 40MM SST MULTIAXIAL | In distribution |
| 14-572555C | 7.5MM(D) X 55MM SST CANNULATED | In distribution |
| 14-572355C | 5.5MM(D) X 55MM SST CANNULATED | In distribution |
| 14-574235 | 4.75MM(D) X 35MM FIXED SCREW | In distribution |
| 14-577540 | 7.5MM(D) X 40MM SST MULTIAXIAL | In distribution |
| 14-574340C | 5.5MM(D) X 40MM SST CANNULATED | In distribution |
| 14-574435 | 6.5MM(D) X 35 FIXED SCREW | In distribution |
| 14-577545 | 7.5MM(D) X 45MM SST MULTIAXIAL | In distribution |
| 14-574445 | 6.5MM(D) X 45MM FIXED SCREW | In distribution |
| 14-574445C | 6.5MM(D) X 45MM SST CANNULATED | In distribution |
| 14-572440C | 6.5MM(D) X 40MM SST CANNULATED | In distribution |
| 14-574655 | 8.5MM(D) X 55MM FIXED SCREW | In distribution |
| 14-572635C | 8.5MM(D) X 35MM SST CANNULATED | In distribution |
| 14-574355 | 5.5MM(D) X 55MM FIXED SCREW | In distribution |
| 14-574635C | 8.5MM(D) X 35MM SST CANNULATED | In distribution |
| 14-577430 | 6.5MM(D) X 30MM SST MULTIAXIAL | In distribution |
| 14-572545C | 7.5MM(D) X 45MM SST CANNULATED | In distribution |
| 14-572655C | 8.5MM(D) X 55MM SST CANNULATED | In distribution |
| 14-574530C | 7.5MM(D) X 30MM SST CANNULATED | In distribution |
| 14-577350 | 5.5MM(D) X 50MM SST MULTIAXIAL | In distribution |
| 14-574335C | 5.5MM(D) X 35MM SST CANNULATED | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
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.