Vitality®
79 catalogue numbers from 07.02047.026, listed by Biomet Spine, United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
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 | 2015-12-01 |
| Record revised | 2025-07-02 (version 8) |
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 |
|---|---|---|
| 07.02047.026 | Uniplanar Reduction Screw, Ø5.0mm X 55mm | In distribution |
| 07.02026.001 | Lateral Offset Connector – Closed, S00°, 10mm | In distribution |
| 07.02047.013 | Uniplanar Reduction Screw, Ø4.5mm X 35mm | In distribution |
| 07.02042.052 | Uniplanar Screw, Ø6.0mm X 35mm | In distribution |
| 07.02048.006 | Transverse Connector, Fixed, 31mm Wide X Ø5.5mm | In distribution |
| 07.02047.122 | Uniplanar Reduction Screw, Ø7.5mm X 70mm | In distribution |
| 07.02000.129 | Polyaxial Screw, Ø7.5mm X 105mm | In distribution |
| 07.02047.091 | Uniplanar Reduction Screw, Ø7.0mm X 20mm | In distribution |
| 07.02047.058 | Uniplanar Reduction Screw, Ø6.0mm X 65mm | In distribution |
| 07.02040.022 | Monoaxial Screw, Ø5.0mm X 35mm | In distribution |
| 07.02000.045 | Polyaxial Screw, Ø5.5mm X 105mm | In distribution |
| 07.02042.089 | Uniplanar Screw, Ø6.5mm X 115mm | In distribution |
| 07.02040.117 | Monoaxial Screw, Ø7.5mm X 45mm | In distribution |
| 07.02000.096 | Polyaxial Screw, Ø7.0mm X 45mm | In distribution |
| 07.02047.008 | Uniplanar Reduction Screw, Ø4.0mm X 55mm | In distribution |
| 07.02047.074 | Uniplanar Reduction Screw, Ø6.5mm X 40mm | In distribution |
| 07.02047.114 | Uniplanar Reduction Screw, Ø7.5mm X 30mm | In distribution |
| 07.02040.025 | Monoaxial Screw, Ø5.0mm X 50mm | In distribution |
| 07.02047.076 | Uniplanar Reduction Screw, Ø6.5mm X 50mm | In distribution |
| 07.02000.084 | Polyaxial Screw, Ø6.5mm X 90mm | In distribution |
| 07.02000.038 | Polyaxial Screw, Ø5.5mm X 70mm | In distribution |
| 07.02042.033 | Uniplanar Screw, Ø5.5mm X 45mm | In distribution |
| 07.02012.122 | Polyaxial Closed Iliac Screw, Ø7.5mm X 70mm | In distribution |
| 07.02047.007 | Uniplanar Reduction Screw, Ø4.0mm X 50mm | In distribution |
| 07.02000.067 | Polyaxial Screw, Ø6.0mm X 110mm | In distribution |
| 07.02042.115 | Uniplanar Screw, Ø7.5mm X 35mm | In distribution |
| 07.02042.096 | Uniplanar Screw, Ø7.0mm X 45mm | In distribution |
| 07.02042.060 | Uniplanar Screw, Ø6.0mm X 75mm | In distribution |
| 07.02000.037 | Polyaxial Screw, Ø5.5mm X 65mm | In distribution |
| 07.02040.024 | Monoaxial Screw, Ø5.0mm X 45mm | In distribution |
| 07.02026.017 | Lateral Offset Connector – Closed, S00°, 100mm | In distribution |
| 07.02014.022 | Rod, Ti Ø5.5mm X 125mm, Straight | In distribution |
| 07.02000.099 | Polyaxial Screw, Ø7.0mm X 60mm | In distribution |
| 07.02047.112 | Uniplanar Reduction Screw, Ø7.5mm X 20mm | In distribution |
| 07.02047.066 | Uniplanar Reduction Screw, Ø6.0mm X 105mm | In distribution |
| 07.02000.123 | Polyaxial Screw, Ø7.5mm X 75mm | In distribution |
| 07.02048.021 | Transverse Connector, Fixed, 29mm Wide X Ø6.0mm | In distribution |
| 07.02042.056 | Uniplanar Screw, Ø6.0mm X 55mm | In distribution |
| 07.02026.110 | Lateral Offset Connector – Closed, R25°, 150mm | In distribution |
| 07.02040.078 | Monoaxial Screw, Ø6.5mm X 60mm | In distribution |
| 07.02050.070 | Polyaxial Open Iliac Screw, Ø6.5mm X 20mm | In distribution |
| 07.02042.112 | Uniplanar Screw, Ø7.5mm X 20mm | In distribution |
| 07.02026.066 | Lateral Offset Connector – Closed, R15°, 150mm | In distribution |
| 07.02042.084 | Uniplanar Screw, Ø6.5mm X 90mm | In distribution |
| 07.02042.087 | Uniplanar Screw, Ø6.5mm X 105mm | In distribution |
| 07.02047.052 | Uniplanar Reduction Screw, Ø6.0mm X 35mm | In distribution |
| 07.02047.042 | Uniplanar Reduction Screw, Ø5.5mm X 90mm | In distribution |
| 07.02047.048 | Uniplanar Reduction Screw, Ø5.5mm X 120mm | In distribution |
| 07.02048.005 | Transverse Connector, Fixed, 29mm Wide X Ø5.5mm | In distribution |
| 07.02026.003 | Lateral Offset Connector – Closed, S00°, 20mm | In distribution |
| 07.02000.047 | Polyaxial Screw, Ø5.5mm X 115mm | In distribution |
| 07.02028.002 | Rod Connector – Lateral, Closed, 2 Screw, 5.5/6.0mm X 3.5mm | In distribution |
| 07.02026.053 | Lateral Offset Connector – Closed, R15°, 50mm | In distribution |
| 07.02000.102 | Polyaxial Screw, Ø7.0mm X 75mm | In distribution |
| 07.02040.076 | Monoaxial Screw, Ø6.5mm X 50mm | In distribution |
| 07.02042.063 | Uniplanar Screw, Ø6.0mm X 90mm | In distribution |
| 07.02040.115 | Monoaxial Screw, Ø7.5mm X 35mm | In distribution |
| 07.02042.010 | Uniplanar Screw, Ø4.5mm X 20mm | In distribution |
| 07.02040.034 | Monoaxial Screw, Ø5.5mm X 50mm | In distribution |
| 07.02000.131 | Polyaxial Screw, Ø7.5mm X 115mm | In distribution |
| 07.02047.060 | Uniplanar Reduction Screw, Ø6.0mm X 75mm | In distribution |
| 07.02047.115 | Uniplanar Reduction Screw, Ø7.5mm X 35mm | In distribution |
| 07.02026.044 | Lateral Offset Connector – Closed, L15°, 150mm | In distribution |
| 07.02040.072 | Monoaxial Screw, Ø6.5mm X 30mm | In distribution |
| 07.02005.258 | Polyaxial Reduction Screw, Ø10.5mm X 120mm | In distribution |
| 07.02042.125 | Uniplanar Screw, Ø7.5mm X 85mm | In distribution |
| 07.02012.124 | Polyaxial Closed Iliac Screw, Ø7.5mm X 80mm | In distribution |
| 07.02040.026 | Monoaxial Screw, Ø5.0mm X 55mm | In distribution |
| 07.02000.104 | Polyaxial Screw, Ø7.0mm X 85mm | In distribution |
| 07.02047.125 | Uniplanar Reduction Screw, Ø7.5mm X 85mm | In distribution |
| 07.02047.083 | Uniplanar Reduction Screw, Ø6.5mm X 85mm | In distribution |
| 07.02012.132 | Polyaxial Closed Iliac Screw, Ø7.5mm X 120mm | In distribution |
| 07.02012.130 | Polyaxial Closed Iliac Screw, Ø7.5mm X 110mm | In distribution |
| 07.02042.042 | Uniplanar Screw, Ø5.5mm X 90mm | In distribution |
| 07.02047.079 | Uniplanar Reduction Screw, Ø6.5mm X 65mm | In distribution |
| 07.02047.012 | Uniplanar Reduction Screw, Ø4.5mm X 30mm | In distribution |
| 07.02050.256 | Polyaxial Open Iliac Screw, Ø10.5mm X 110mm | In distribution |
| 07.02047.081 | Uniplanar Reduction Screw, Ø6.5mm X 75mm | In distribution |
| 07.02047.094 | Uniplanar Reduction Screw, Ø7.0mm X 35mm | 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.