Polaris™ 5.5 Spinal System
62 catalogue numbers from 14-578820R, listed by Biomet Spine, United States, under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
62catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2020-09-30 |
| 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 |
|---|---|---|
| 14-578820R | 5.5 TI 10.5X20MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578504 | 5.5 TI 7.5X120MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578430 | 5.5 TI 6.5X30MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578675 | 5.5 TI 8.5X75MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578230R | 5.5 TI 4.75X30MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578285 | 5.5 TI 4.75X85MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578270 | 5.5 TI 4.75X70MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578650 | 5.5 TI 8.5X50MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578625R | 5.5 TI 8.5X25MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578550 | 5.5 TI 7.5X50MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-5537L | In distribution | |
| 14-578710 | 5.5 TI 9.5 X 150MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578255 | 5.5 TI 4.75X55MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578203 | 5.5 TI 4.75X115MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578505 | 5.5 TI 7.5X125MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578540R | 5.5 TI 7.5X40MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578699 | 5.5 TI 8.5X100MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578755 | 5.5 TI 9.5 X 55MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578650R | 5.5 TI 8.5X50MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578407R | 5.5 TI 6.5X135MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578207R | 5.5 TI 4.75X135MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578899R | 5.5 TI 10.5X100MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578310 | 5.5 TI 5.5X150MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578308 | 5.5 TI 5.5X140MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578680 | 5.5 TI 8.5X80MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578780R | 5.5 TI 9.5X80MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578810 | 5.5 TI 10.5 X150MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578260 | 5.5 TI 4.75X60MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578745 | 5.5 TI 9.5 X 45MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578405R | 5.5 TI 6.5X125MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578399R | 5.5 TI 5.5X100MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578406 | 5.5 TI 6.5X130MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578750R | 5.5 TI 9.5X50MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578695R | 5.5 TI 8.5X95MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578306R | 5.5 TI 5.5X130MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578235 | 5.5 TI 4.75X35MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578403 | 5.5 TI 6.5X115MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578755R | 5.5 TI 9.5X55MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 20005541R | In distribution | |
| 14-578375 | 5.5 TI 5.5X75MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578410R | 5.5 TI 6.5X150MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578699R | 5.5 TI 8.5X100MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578395R | 5.5 TI 5.5X95MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578885 | 5.5 TI 10.5 X 85MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578770 | 5.5 TI 9.5 X 70MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578770R | 5.5 TI 9.5X70MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 20005539R | In distribution | |
| 14-578802 | 5.5 TI 10.5 X110MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578455 | 5.5 TI 6.5X55MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578370R | 5.5 TI 5.5X70MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578760 | 5.5 TI 9.5 X 60MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578345 | 5.5 TI 5.5X45MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578585 | 5.5 TI 7.5X85MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578710R | 5.5 TI 9.5X150MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578705 | 5.5 TI 9.5 X 125MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578307 | 5.5 TI 5.5X135MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578270R | 5.5 TI 4.75X70MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578640 | 5.5 TI 8.5X40MM TRANSLATION TRANSLATION SCREW | In distribution |
| 20005541L | In distribution | |
| 14-578208 | 5.5 TI 4.75X140MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-578210R | 5.5 TI 4.75X150MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578745R | 5.5 TI 9.5X45MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
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.