Spine System
34 catalogue numbers from 6589M, 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
34catalogue 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 | 2025-01-03 (version 9) |
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 |
|---|---|---|
| 6589M | MULTI-AXIAL SCREW (TI) 8.0MM (D) X 80MM (L) W/COLLAR | In distribution |
| 14-501150 | PEDICLE HOOK, SMALL | In distribution |
| 6941 | HF INTEGRAL SCREW-6.35 8.0MM X 35MM TI | In distribution |
| 6804MP | VLS SCREW W/FLUTES-6.35 4.75MM X 25MM TI | In distribution |
| 14-501158 | RIGHT ANGLED HOOK, LARGE | In distribution |
| 14-501165 | NARROW REDUCED LAMINAR HOOK SMALL | In distribution |
| 14-501304 | 7.5MM(D) X 30MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 14-501332 | 8.5MM(D) X 70MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| LV01054 | LARGE HANDLE OCC. SCR. STARTER LINEUM | In distribution |
| 6803MP | VLS SCREW W/FLUTES-6.35 4.75MM X 20MM TI | In distribution |
| LV00886 | 4.0 MM TAPERED TAP, LINEUM | In distribution |
| 6583M | MULTI-AXIAL SCREW (TI) 8.0MM (D) X 40MM (L) W/COLLAR | In distribution |
| 14-500780 | DOMINO, SS 5.5MM X 5.5MM AXIAL | In distribution |
| LV01404 | 5.0mm Pedicle Access Tool | In distribution |
| 14-501327 | 8.5MM(D) X 45MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 6943 | HF INTEGRAL SCREW-6.35 8.0MM X 40MM TI | In distribution |
| 14-501316 | 7.5MM(D) X 90MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-500785 | DOMINO, SS 6.35MMX6.35MM AXIAL | In distribution |
| 14-501154 | LEFT ANGLED HOOK, MEDIUM | In distribution |
| LV00492 | EXTENDED SCREW INSERTER LINEUM | In distribution |
| 14-501337 | 8.5MM(D) X 95MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-501323 | 8.5MM(D) X 25MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 6584M | MULTI-AXIAL SCREW (TI) 8.0MM (D) X 45MM (L) W/COLLAR | In distribution |
| LV00885 | 3.5 MM TAPERED TAP, LINEUM | In distribution |
| 6807M | MULTI-AXIAL SCREW (TI) 4.75MM(D) X 40MM(L) W/COLLAR | In distribution |
| 6586M | MULTI-AXIAL SCREW (TI) 8.0MM (D) X 55MM (L) W/COLLAR | In distribution |
| 14-501333 | 8.5MM(D) X 75MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 6581M | MULTI-AXIAL SCREW (TI) 8.0MM (D) X 30MM (L) W/COLLAR | In distribution |
| 14-501178 | EXTENDED LAMINAR HOOK, MEDIUM | In distribution |
| 14-501305 | 7.5MM(D) X 35MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 14-501168 | LEFT OFFSET HOOK, SMALL | In distribution |
| 14-501172 | RIGHT OFFSET HOOK, MEDIUM | In distribution |
| 14-501294 | 6.5MM(D) X 80MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 6551MP | VLS SCREW W/FLUTES-6.35MM 4.0MM X 25MM TI | 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.