Polaris 6.35 SST Spinal System
22 catalogue numbers from 14-577550, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
22catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 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 |
|---|---|---|
| 14-577550 | 7.5MM(D) X 50MM SST MULTIAXIAL | In distribution |
| 14-575418 | 60CM BE ROD, STANDARD, 6.35SST | In distribution |
| 14-574225 | 4.75MM(D) X 25MM FIXED SCREW | In distribution |
| 14-572540C | 7.5MM(D) X 40MM SST CANNULATED | In distribution |
| 14-574450 | 6.5MM(D) X 50MM FIXED SCREW | In distribution |
| 14-577355 | 5.5MM(D) X 55MM SST MULTIAXIAL | In distribution |
| 14-575155 | 20MM FIXED CROSS CONNECTOR | In distribution |
| 14-577450 | 6.5MM(D) X 50MM SST MULTIAXIAL | In distribution |
| 14-574230 | 4.75MM(D) X 30MM FIXED SCREW | In distribution |
| 14-572350C | 5.5MM(D) X 50MM SST CANNULATED | In distribution |
| 14-572450C | 6.5MM(D) X 50MM SST CANNULATED | In distribution |
| 14-574540 | 7.5MM(D) X 40MM FIXED SCREW | In distribution |
| 14-574245 | 4.75MM(D) X 45MM FIXED SCREW | In distribution |
| 14-574455 | 6.5MM(D) X 55MM FIXED SCREW | In distribution |
| 14-574455C | 6.5MM(D) X 55MM SST CANNULATED | In distribution |
| 14-577345 | 5.5MM(D) X 45MM SST MULTIAXIAL | In distribution |
| 14-575168 | ANGULATING CROSS CONNECTOR,XXS | In distribution |
| 14-574630 | 8.5MM(D) X 30MM FIXED SCREW | In distribution |
| 14-575143 | 14MM FIXED CROSS CONNECTOR | In distribution |
| 14-574355C | 5.5MM(D) X 55MM SST CANNULATED | In distribution |
| 14-574650 | 8.5MM(D) X 50MM FIXED SCREW | In distribution |
| 14-574330C | 5.5MM(D) X 30MM SST CANNULATED | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.