Polaris 6.35 TI Spinal System
50 catalogue numbers from 14-513140R, listed by Biomet Spine, United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
50catalogue 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, Spinal Pedicle Fixation
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle 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 |
|---|---|---|
| 14-513140R | 4.0MM X 40MM REDUCTION | In distribution |
| 14-513425R | 6.5MM X 25MM REDUCTION | In distribution |
| 14-513335R | 5.5MM X 35MM REDUCTION | In distribution |
| 14-513435R | 6.5MM X 35MM REDUCTION | In distribution |
| 14-513785R | 9.5MM X 85MM REDUCTION | In distribution |
| 14-515390 | 6.35 TI 5.5X90MM MAS REDUC | In distribution |
| 14-513535R | 7.5MM X 35MM REDUCTION | In distribution |
| 14-515475 | 6.35 TI 6.5X75MM MAS REDUC | In distribution |
| 14-513720R | 9.5MM X 20MM REDUCTION | In distribution |
| 14-515625 | 6.35 TI 8.5X25MM MAS REDUC | In distribution |
| 14-513495R | 6.5MM X 95MM REDUCTION | In distribution |
| 14-513465R | 6.5MM X 65MM REDUCTION | In distribution |
| 14-515680 | 6.35 TI 8.5X80MM MAS REDUC | In distribution |
| 14-513565R | 7.5MM X 65MM REDUCTION | In distribution |
| 14-513290R | 4.75MM X 90MM REDUCTION | In distribution |
| 14-515750 | 6.35 TI 9.5X50MM MAS REDUC | In distribution |
| 14-515645 | 6.35 TI 8.5X45MM MAS REDUC | In distribution |
| 14-515330 | 6.35 TI 5.5X30MM MAS REDUC | In distribution |
| 14-513325R | 5.5MM X 25MM REDUCTION | In distribution |
| 14-515350 | 6.35 TI 5.5X50MM MAS REDUC | In distribution |
| 14-515470 | 6.35 TI 6.5X70MM MAS REDUC | In distribution |
| 14-515730 | 6.35 TI 9.5X30MM MAS REDUC | In distribution |
| 14-513750R | 9.5MM X 50MM REDUCTION | In distribution |
| 14-513765R | 9.5MM X 65MM REDUCTION | In distribution |
| 14-515885 | 6.35 TI 10.5X85MM MAS REDUC | In distribution |
| 14-515695 | 6.35 TI 8.5X95MM MAS REDUC | In distribution |
| 14-513690R | 8.5MM X 90MM REDUCTION | In distribution |
| 14-515865 | 6.35 TI 10.5X65MM MAS REDUC | In distribution |
| 14-515765 | 6.35 TI 9.5X65MM MAS REDUC | In distribution |
| 14-515465 | 6.35 TI 6.5X65MM MAS REDUC | In distribution |
| 14-513625R | 8.5MM X 25MM REDUCTION | In distribution |
| 14-515325 | 6.35 TI 5.5X25MM MAS REDUC | In distribution |
| 14-515460 | 6.35 TI 6.5X60MM MAS REDUC | In distribution |
| 14-515880 | 6.35 TI 10.5X80MM MAS REDUC | In distribution |
| 14-513375R | 5.5MM X 75MM REDUCTION | In distribution |
| 14-513540R | 7.5MM X 40MM REDUCTION | In distribution |
| 14-513385R | 5.5MM X 85MM REDUCTION | In distribution |
| 14-513455R | 6.5MM X 55MM REDUCTION | In distribution |
| 14-513780R | 9.5MM X 80MM REDUCTIO | In distribution |
| 14-515565 | 6.35 TI 7.5X65MM MAS REDUC | In distribution |
| 14-515395 | 6.35 TI 5.5X95MM MAS REDUC | In distribution |
| 14-513670R | 8.5MM X 70MM REDUCTION | In distribution |
| 14-513675R | 8.5MM X 75MM REDUCTION | In distribution |
| 14-515420 | 6.35 TI 6.5X20MM MAS REDUC | In distribution |
| 14-513155R | 4.0MM X 55MM REDUCTION | In distribution |
| 14-515855 | 6.35 TI 10.5X55MM MAS REDUC | In distribution |
| 14-513390R | 5.5MM X 90MM REDUCTION | In distribution |
| 14-513895R | 10.5MM X 95MM REDUCTION | In distribution |
| 14-515620 | 6.35 TI 8.5X20MM MAS REDUC | In distribution |
| 14-515530 | 6.35 TI 7.5X30MM MAS REDUC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle 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.