Polaris 5.5 SST Spine SYS
65 catalogue numbers from 14-506390R, 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
65catalogue 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 |
|---|---|---|
| 14-506390R | 5.5MM X 90MM REDUCTION | In distribution |
| 14-506870R | 10.5MM X 70MM REDUCTION | In distribution |
| 14-506499R | 6.5MM X 100MM REDUCTION | In distribution |
| 14-506755R | 9.5MM X 55MM REDUCTION | In distribution |
| 14-506460 | 6.5MM X 60MM UNIPLANAR SCREW | In distribution |
| 14-506645R | 8.5MM X 45MM REDUCTION | In distribution |
| 14-506860 | 10.5MM X 60MM UNIPLANAR SCREW | In distribution |
| 14-506880R | 10.5MM X 80MM REDUCTION | In distribution |
| 14-506795R | 9.5MM X 95MM REDUCTION | In distribution |
| 14-506630R | 8.5MM X 30MM REDUCTION | In distribution |
| 14-506670 | 8.5MM X 70MM UNIPLANAR SCREW | In distribution |
| 14-506435 | 6.5MM X 35MM UNIPLANAR SCREW | In distribution |
| 14-506265R | 4.75MM X 65MM REDUCTION | In distribution |
| 14-506125R | 4.0MM X 25MM REDUCTION | In distribution |
| 14-506650 | 8.5MM X 50MM UNIPLANAR SCREW | In distribution |
| 14-506485R | 6.5MM X 85MM REDUCTION | In distribution |
| 14-506145R | 4.0MM X 45MM UNIPLANAR SCREW | In distribution |
| 14-506530R | 7.5MM X 30MM REDUCTION | In distribution |
| 14-506780 | 9.5MM X 80MM UNIPLANAR SCREW | In distribution |
| 14-506780R | 9.5MM X 80MM REDUCTION | In distribution |
| 14-506325 | 5.5MM X 25MM UNIPLANAR SCREW | In distribution |
| 14-506290 | 4.75MM X 90MM UNIPLANAR SCREW | In distribution |
| 14-506335R | 5.5MM X 35MM REDUCTION | In distribution |
| 14-506695R | 8.5MM X 95MM REDUCTION | In distribution |
| 14-506899 | 10.5MM X 100MM UNIPLANAR SCREW | In distribution |
| 14-506740R | 9.5MM X 40MM REDUCTION | In distribution |
| 14-506665 | 8.5MM X 65MM UNIPLANAR SCREW | In distribution |
| 14-506860R | 10.5MM X 60MM REDUCTION | In distribution |
| 14-506475R | 6.5MM X 75MM REDUCTION | In distribution |
| 14-506880 | 10.5MM X 80MM UNIPLANAR SCREW | In distribution |
| 14-506775R | 9.5MM X 75MM REDUCTION | In distribution |
| 14-506425R | 6.5MM X 25MM REDUCTION | In distribution |
| 14-506565 | 7.5MM X 65MM UNIPLANAR SCREW | In distribution |
| 14-507340 | 5.5 X 40MM MULTIAXIAL | In distribution |
| 14-506395 | 5.5MM X 95MM UNIPLANAR SCREW | In distribution |
| 14-506280 | 4.75MM X 80MM UNIPLANAR SCREW | In distribution |
| 14-506650R | 8.5MM X 50MM REDUCTION | In distribution |
| 14-506690 | 8.5MM X 90MM UNIPLANAR SCREW | In distribution |
| 14-507350 | 5.5 X 50MM MULTIAXIAL | In distribution |
| 14-506290R | 4.75MM X 90MM REDUCTION | In distribution |
| 14-506720 | 9.5MM X 20MM UNIPLANAR SCREW | In distribution |
| 14-506195 | 4.0MM X 95MM UNIPLANAR SCREW | In distribution |
| 14-506370 | 5.5MM X 70MM UNIPLANAR SCREW | In distribution |
| 14-506585R | 7.5MM X 85MM REDUCTION | In distribution |
| 14-506855 | 10.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 14-506825 | 10.5MM X 25MM UNIPLANAR SCREW | In distribution |
| 14-506540 | 7.5MM X 40MM UNIPLANAR SCREW | In distribution |
| 14-506855R | 10.5MM X 55MM REDUCTION | In distribution |
| 14-506770R | 9.5MM X 70MM REDUCTION | In distribution |
| 14-506475 | 6.5MM X 75MM UNIPLANAR SCREW | In distribution |
| 14-506225R | 4.75MM X 25MM REDUCTION | In distribution |
| 14-506260R | 4.75MM X 60MM REDUCTION | In distribution |
| 14-506790R | 9.5MM X 90MM REDUCTION | In distribution |
| 14-506675 | 8.5MM X 75MM UNIPLANAR SCREW | In distribution |
| 14-506680 | 8.5MM X 80MM UNIPLANAR SCREW | In distribution |
| 14-506540R | 7.5MM X 40MM REDUCTION | In distribution |
| 14-506399 | 5.5MM X 100MM UNIPLANAR SCREW | In distribution |
| 14-506365 | 5.5MM X 65MM UNIPLANAR SCREW | In distribution |
| 14-507530 | 7.5 X 30MM MULTIAXIAL | In distribution |
| 14-506745 | 9.5MM X 45MM UNIPLANAR SCREW | In distribution |
| 14-506130R | 4.0MM X 30MM REDUCTION | In distribution |
| 14-506455R | 6.5MM X 55MM REDUCTION | In distribution |
| 14-506299R | 4.75MM X 100MM REDUCTION | In distribution |
| 14-506175 | 4.0MM X 75MM UNIPLANAR SCREW | In distribution |
| 14-506595 | 7.5MM X 95MM UNIPLANAR SCREW | 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.