Polaris 6.35 TI Spinal System
30 catalogue numbers from 14-515435, 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
30catalogue 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 |
|---|---|---|
| 14-515435 | 6.35 TI 6.5X35MM MAS REDUC | In distribution |
| 14-513340R | 5.5MM X 40MM REDUCTION | In distribution |
| 14-513475R | 6.5MM X 75MM REDUCTION | In distribution |
| 14-515560 | 6.35 TI 7.5X60MM MAS REDUC | In distribution |
| 14-513640R | 8.5MM X 40MM REDUCTION | In distribution |
| 14-515260 | 6.35 TI 4.75X60MM MAS REDUC | In distribution |
| 14-515875 | 6.35 TI 10.5X75MM MAS REDUC | In distribution |
| 14-515790 | 6.35 TI 9.5X90MM MAS REDUC | In distribution |
| 14-515340 | 6.35 TI 5.5X40MM MAS REDUC | In distribution |
| 14-515820 | 6.35 TI 10.5X20MM MAS REDUC | In distribution |
| 14-515335 | 6.35 TI 5.5X35MM MAS REDUC | In distribution |
| 14-515380 | 6.35 TI 5.5X80MM MAS REDUC | In distribution |
| 14-513380R | 5.5MM X 80MM REDUCTION | In distribution |
| 14-515225 | 6.35 TI 4.75X25MM MAS REDUC | In distribution |
| 14-513880R | 10.5MM X 80MM REDUCTION | In distribution |
| 14-513240R | 4.75MM X 40MM REDUCTION | In distribution |
| 14-515455 | 6.35 TI 6.5X55MM MAS REDUC | In distribution |
| 14-515655 | 6.35 TI 8.5X55MM MAS REDUC | In distribution |
| 14-513485R | 6.5MM X 85MM REDUCTION | In distribution |
| 14-513875R | 10.5MM X 75MM REDUCTION | In distribution |
| 14-513230R | 4.75MM X 30MM REDUCTION | In distribution |
| 14-515445 | 6.35 TI 6.5X45MM MAS REDUC | In distribution |
| 14-513699R | 8.5MM X 100MM REDUCTION | In distribution |
| 14-513650R | 8.5MM X 50MM REDUCTION | In distribution |
| 14-515725 | 6.35 TI 9.5X25MM MAS REDUC | In distribution |
| 14-513165R | 4.0MM X 65MM REDUCTION | In distribution |
| 14-513440R | 6.5MM X 40MM REDUCTION | In distribution |
| 14-513730R | 9.5MM X 30MM REDUCTION | In distribution |
| 14-515635 | 6.35 TI 8.5X35MM MAS REDUC | In distribution |
| 14-513870R | 10.5MM X 70MM REDUCTION | 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.