Polaris 6.35 TI Spinal System
48 catalogue numbers from 14-515795, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
48catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 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 |
|---|---|---|
| 14-515795 | 6.35 TI 9.5X95MM MAS REDUC | In distribution |
| 14-515745 | 6.35 TI 9.5X45MM MAS REDUC | In distribution |
| 14-513299R | 4.75MM X 100MM REDUCTION | In distribution |
| 14-513825R | 10.5MM X 25MM REDUCTION | In distribution |
| 14-515255 | 6.35 TI 4.75X55MM MAS REDUC | In distribution |
| 14-515299 | 6.35 TI 4.75X100MM MAS REDUC | In distribution |
| 14-515550 | 6.35 TI 7.5X50MM MAS REDUC | In distribution |
| 14-513630R | 8.5MM X 30MM REDUCTION | In distribution |
| 14-515660 | 6.35 TI 8.5X60MM MAS REDUC | In distribution |
| 14-513799R | 9.5MM X 100MM REDUCTION | In distribution |
| 14-513199R | 4.0MM X 100MM REDUCTION | In distribution |
| 14-513790R | 9.5MM X 90MM REDUCTION | In distribution |
| 14-515685 | 6.35 TI 8.5X85MM MAS REDUC | In distribution |
| 14-515890 | 6.35 TI 10.5X90MM MAS REDUC | In distribution |
| 14-513370R | 5.5MM X 70MM REDUCTION | In distribution |
| 14-515870 | 6.35 TI 10.5X70MM MAS REDUC | In distribution |
| 14-513260R | 4.75MM X 60MM REDUCTION | In distribution |
| 14-513480R | 6.5MM X 80MM REDUCTION | In distribution |
| 14-515245 | 6.35 TI 4.75X45MM MAS REDUC | In distribution |
| 14-513520R | 7.5MM X 20MM REDUCTION | In distribution |
| 14-513235R | 4.75MM X 35MM REDUCTION | In distribution |
| 14-515360 | 6.35 TI 5.5X60MM MAS REDUC | In distribution |
| 14-515430 | 6.35 TI 6.5X30MM MAS REDUC | In distribution |
| 14-513275R | 4.75MM X 75MM REDUCTION | In distribution |
| 14-513490R | 6.5MM X 90MM REDUCTION | In distribution |
| 14-513775R | 9.5MM X 75MM REDUCTION | In distribution |
| 14-515599 | 6.35 TI 7.5X100MM MAS REDUC | In distribution |
| 14-513350R | 5.5MM X 50MM REDUCTION | In distribution |
| 14-515280 | 6.35 TI 4.75X80MM MAS REDUC | In distribution |
| 14-515295 | 6.35 TI 4.75X95MM MAS REDUC | In distribution |
| 14-515760 | 6.35 TI 9.5X60MM MAS REDUC | In distribution |
| 14-513185R | 4.0MM X 85MM REDUCTION | In distribution |
| 14-513245R | 4.75MM X 45MM REDUCTION | In distribution |
| 14-515285 | 6.35 TI 4.75X85MM MAS REDUC | In distribution |
| 14-515840 | 6.35 TI 10.5X40MM MAS REDUC | In distribution |
| 14-515755 | 6.35 TI 9.5X55MM MAS REDUC | In distribution |
| 14-513145R | 4.0MM X 45MM REDUCTION | In distribution |
| 14-515535 | 6.35 TI 7.5X35MM MAS REDUC | In distribution |
| 14-513860R | 10.5MM X 60MM REDUCTION | In distribution |
| 14-513450R | 6.5MM X 50MM REDUCTION | In distribution |
| 14-513360R | 5.5MM X 60MM REDUCTION | In distribution |
| 14-513660R | 8.5MM X 60MM REDUCTION | In distribution |
| 14-515525 | 6.35 TI 7.5X25MM MAS REDUC | In distribution |
| 14-513735R | 9.5MM X 35MM REDUCTION | In distribution |
| 14-515825 | 6.35 TI 10.5X25MM MAS REDUC | In distribution |
| 14-515235 | 6.35 TI 4.75X35MM MAS REDUC | In distribution |
| 14-513470R | 6.5MM X 70MM REDUCTION | In distribution |
| 14-515780 | 6.35 TI 9.5X80MM MAS REDUC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103393 | 2011-02-02 |
| K080646 | 2008-05-02 |
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.