Spine System
60 catalogue numbers from LV00531, listed by Biomet Spine, United States, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
60catalogue 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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2020-07-13 |
| Record revised | 2025-07-02 (version 7) |
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 |
|---|---|---|
| LV00531 | LINEUM LOCKING SCREW INSERTER | In distribution |
| 14-500774 | 4.5MM X 6.0MM AXIAL SST DOMINO | In distribution |
| 14-501159 | WIDE LAMINAR HOOK, SMALL | In distribution |
| 6009 | 120MM STRAIGHT CP TI ROD 6.35MM DIA X 12CM LGTH | In distribution |
| LV01405 | 6.0mm Pedicle Access Tool | In distribution |
| 6203 | DOUBLE HEX SET SCREW (TI) | In distribution |
| 6424 | PRE-CURVED CP TI ROD 70MM 6.35MM DIA | In distribution |
| 6016 | 480MM STRAIGHT CP TI ROD W/HEX 6.35MM DIA X 48CM LGTH | In distribution |
| 14-575616 | WASHER ANTERIOR, SST POLARIS X-LARGE | In distribution |
| 14-501157 | RIGHT ANGLED HOOK, MEDIUM | In distribution |
| 6710 | POLARIS 6.35 DEROTATION PLUG TITANIUM | In distribution |
| LV01403 | 4.0mm Pedicle Access Tool | In distribution |
| 6005 | 50MM STRAIGHT CP TI ROD 6.35MM DIA X 5CM LGTH | In distribution |
| 6435 | 6.35MM X 5CM TI ALLOY CURVED ROD | In distribution |
| 14-501312 | 7.5MM(D) X 70MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-501306 | 7.5MM(D) X 40MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 14-501317 | 7.5MM(D) X 95MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 6451 | HELICAL FLANGE PLUG | In distribution |
| 14-501176 | ANGLED BLADE HOOK, LARGE | In distribution |
| 14-501152 | PEDICLE HOOK, LARGE | In distribution |
| 6861 | FIXATION WASHER – MEDIUM | In distribution |
| 6426 | PRE-CURVED CP TI ROD 90MM 6.35MM DIA | In distribution |
| 6427 | PRE-CURVED CP TI ROD 100MM 6.35MM DIA | In distribution |
| 6108M | MULTI-AXIAL SCREW (TI) 5.5MM (D) X 45MM (L) W/COLLAR | In distribution |
| 14-501338 | 8.5MM(D) X 100MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-501324 | 8.5MM(D) X 30MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 6017 | 60CM CP TI ROD W/HEX 6.35MM DIA | In distribution |
| 6805MP | VLS SCREW W/FLUTES-6.35 4.75MM X 30MM TI | In distribution |
| 6107M | MULTI-AXIAL SCREW (TI) 5.5MM (D) X 40MM (L) W/COLLAR | In distribution |
| 14-513395R | 5.5MM X 95MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-501221 | TI HF LATERAL CONNECTOR 75MM EXTENDED – 6.35 | In distribution |
| LV00854 | LINEUM 3.0MM TAPERED TAP | In distribution |
| 14-500781 | 5.5MM X 6.0MM AXIAL SST DOMINO | In distribution |
| 6437 | 6.35MM X 7CM TI ALLOY CURVED ROD | In distribution |
| 6806MP | VLS SCREW W/FLUTES-6.35 4.75MM X 35MM TI | In distribution |
| 14-501308 | 7.5MM(D) X 50MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 6119M | MULTI-AXIAL SCREW (TI) 7.0MM (D) X 50MM (L) W/COLLAR | In distribution |
| LV01406 | 7.0mm Pedicle Access Tool | In distribution |
| 6035 | STRAIGHT TI ALLOY ROD 300MM X 6.35MM DIA W/HEX | In distribution |
| 6425 | PRE-CURVED CP TI ROD 80MM 6.35MM DIA | In distribution |
| 14-500775 | 4.5MM X 6.35MM AXIAL SST DOMINO | In distribution |
| 6856 | DOUBLE ROD FIXATION WASHER MEDIUM – RIGHT | In distribution |
| 6114M | MULTI-AXIAL SCREW (TI) 6.5MM (D) X 50MM (L) W/COLLAR | In distribution |
| 14-575614 | WASHER ANTERIOR, SST POLARIS MEDIUM | In distribution |
| 6858 | DOUBLE ROD FIXATION WASHER X-LARGE – RIGHT | In distribution |
| 6946 | HF INTEGRAL SCREW-6.35 8.0MM X 55MM TI | In distribution |
| 14-501220 | TI HF LATERAL CONNECTOR 50MM EXTENDED – 6.35 | In distribution |
| 6115M | MULTI-AXIAL SCREW (TI) 7.0MM (D) X 30MM (L) W/COLLAR | In distribution |
| 14-501164 | NARROW LAMINAR HOOK, LARGE | In distribution |
| 6105M | MULTI-AXIAL SCREW (TI) 5.5MM(D) X 30MM(L) W/COLLAR | In distribution |
| 14-501311 | 7.5MM(D) X 65MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 6582M | MULTI-AXIAL SCREW (TI) 8.0MM (D) X 35MM (L) W/COLLAR | In distribution |
| 6421 | PRE-CURVED CP TI ROD 40MM 6.35MM DIA | In distribution |
| 14-501328 | 8.5MM(D) X 50MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 6006 | 60MM STRAIGHT CP TI ROD 6.35MM DIA X 6CM LGTH | In distribution |
| 6863 | FIXATION WASHER – X-LARGE | In distribution |
| 14-501296 | 6.5MM(D) X 90MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 6806M | MULTI-AXIAL SCREW (TI) 4.75MM(D) X 35MM(L) W/COLLAR | In distribution |
| 6015 | 300MM STRAIGHT CP TI ROD W/HEX 6.35MM DIA X 30CM LGTH | In distribution |
| 6118M | MULTI-AXIAL SCREW (TI) 7.0MM (D) X 45MM (L) W/COLLAR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal 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.