Vital™ MIS Spinal Fixation System
265 catalogue numbers from 825M8035, listed by Biomet Spine, United States, under Thoracolumbosacral Pedicle Screw System. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
265catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2021-04-21 |
| Record revised | 2025-07-02 (version 5) |
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 |
|---|---|---|
| 825M8035 | Ø8.0x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M4525 | Ø4.5x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6000 | Ø6.0x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M4560 | Ø4.5x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5550 | Ø5.5x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9000 | Ø9.0x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5080 | Short Cannulated Tap, Ø8.0mm | In distribution |
| 824M6575 | Ø6.5x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8560 | Ø8.5x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5100 | Short Cannulated Tap, Ø10.0mm | In distribution |
| 825M1025 | Ø10.0x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6090 | Ø6.0x90mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9545 | Ø9.5x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9020 | Ø9.0x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6080 | Ø6.0x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8005 | Ø8.0x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6075 | Ø6.0x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5521 | Ø5.5x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8040 | Ø8.0x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M4545 | Ø4.5x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5105 | Short Cannulated Tap, Ø10.5mm | In distribution |
| 825M1500 | Ø10.5x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6515 | Ø6.5x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6050 | Ø6.0x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1095 | Ø10.0x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5070 | Short Cannulated Tap, Ø7.0mm | In distribution |
| 824M6085 | Ø6.0x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7015 | Ø7.0x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1595 | Ø10.5x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8505 | Ø8.5x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8565 | Ø8.5x65mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5075 | Short Cannulated Tap, Ø7.5mm | In distribution |
| 824M7000 | Ø7.0x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7030 | Ø7.0x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5565 | Ø5.5x65mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7521 | Ø7.5x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5060 | Ø5.0x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6525 | Ø6.5x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9055 | Ø9.0x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5560 | Ø5.5x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5510 | Ø5.5x110mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1540 | Ø10.5x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9570 | Ø9.5x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8590 | Ø8.5x90mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6570 | Ø6.5x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5505 | Ø5.5x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1040 | Ø10.0x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5085 | Short Cannulated Tap, Ø8.5mm | In distribution |
| 824M7515 | Ø7.5x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5025 | Ø5.0x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6540 | Ø6.5x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9525 | Ø9.5x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9021 | Ø9.0x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7585 | Ø7.5x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8520 | Ø8.5x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5575 | Ø5.5x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8555 | Ø8.5x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5040 | Ø5.0x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6530 | Ø6.5x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8080 | Ø8.0x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1015 | Ø10.0x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9085 | Ø9.0x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6565 | Ø6.5x65mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7095 | Ø7.0x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6021 | Ø6.0x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6535 | Ø6.5x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9595 | Ø9.5x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8021 | Ø8.0x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9575 | Ø9.5x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8050 | Ø8.0x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8025 | Ø8.0x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1050 | Ø10.0x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6560 | Ø6.5x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9500 | Ø9.5x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7525 | Ø7.5x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8521 | Ø8.5x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9050 | Ø9.0x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1085 | Ø10.0x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6005 | Ø6.0x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7580 | Ø7.5x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1555 | Ø10.5x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9075 | Ø9.0x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7595 | Ø7.5x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7021 | Ø7.0x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7540 | Ø7.5x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7505 | Ø7.5x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6555 | Ø6.5x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8580 | Ø8.5x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8575 | Ø8.5x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5045 | Short Cannulated Tap, Ø4.5mm | In distribution |
| 825M9095 | Ø9.0x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8030 | Ø8.0x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M4520 | Ø4.5x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7060 | Ø7.0x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6055 | Ø6.0x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1585 | Ø10.5x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5020 | Ø5.0x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7005 | Ø7.0x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8075 | Ø8.0x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5055 | Short Cannulated Tap, Ø5.5mm | In distribution |
| 825M1521 | Ø10.5x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8540 | Ø8.5x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6070 | Ø6.0x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7590 | Ø7.5x90mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6020 | Ø6.0x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9580 | Ø9.5x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9040 | Ø9.0x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1520 | Ø10.5x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9520 | Ø9.5x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M6055 | Short Cannulated P.A.T. Tap, Ø5.5mm | In distribution |
| 824M5055 | Ø5.0x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9555 | Ø9.5x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6585 | Ø6.5x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9005 | Ø9.0x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8570 | Ø8.5x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1590 | Ø10.5x90mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5090 | Short Cannulated Tap, Ø9.0mm | In distribution |
| 824M5035 | Ø5.0x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6500 | Ø6.5x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1545 | Ø10.5x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9521 | Ø9.5x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8500 | Ø8.5x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8525 | Ø8.5x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1550 | Ø10.5x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7500 | Ø7.5x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8060 | Ø8.0x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1045 | Ø10.0x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1005 | Ø10.0x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6030 | Ø6.0x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5590 | Ø5.5x90mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7550 | Ø7.5x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1021 | Ø10.0x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8085 | Ø8.0x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7090 | Ø7.0x90mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5060 | Short Cannulated Tap, Ø6.0mm | In distribution |
| 825M1525 | Ø10.5x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7065 | Ø7.0x65mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5580 | Ø5.5x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7035 | Ø7.0x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5065 | Short Cannulated Tap, Ø6.5mm | In distribution |
| 824M7570 | Ø7.5x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5530 | Ø5.5x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7535 | Ø7.5x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1515 | Ø10.5x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1000 | Ø10.0x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1035 | Ø10.0x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6015 | Ø6.0x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6045 | Ø6.0x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6040 | Ø6.0x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6025 | Ø6.0x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9010 | Ø9.0x110mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5520 | Ø5.5x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9025 | Ø9.0x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8530 | Ø8.5x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6060 | Ø6.0x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1570 | Ø10.5x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8020 | Ø8.0x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6510 | Ø6.5x110mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9080 | Ø9.0x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5515 | Ø5.5x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7080 | Ø7.0x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6580 | Ø6.5x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7075 | Ø7.0x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7010 | Ø7.0x110mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1030 | Ø10.0x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7070 | Ø7.0x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1530 | Ø10.5x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M6045 | Short Cannulated P.A.T. Tap, Ø4.5mm | In distribution |
| 825M8045 | Ø8.0x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1070 | Ø10.0x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9070 | Ø9.0x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1060 | Ø10.0x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M4550 | Ø4.5x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7520 | Ø7.5x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M4555 | Ø4.5x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6065 | Ø6.0x65mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8090 | Ø8.0x90mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1010 | Ø10.0x110mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7040 | Ø7.0x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5595 | Ø5.5x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1020 | Ø10.0x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5570 | Ø5.5x70mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9540 | Ø9.5x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7565 | Ø7.5x65mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5095 | Short Cannulated Tap, Ø9.5mm | In distribution |
| 824M7085 | Ø7.0x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8000 | Ø8.0x100mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8095 | Ø8.0x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9515 | Ø9.5x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5050 | Ø5.0x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7530 | Ø7.5x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7510 | Ø7.5x110mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5045 | Ø5.0x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1065 | Ø10.0x65mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6520 | Ø6.5x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8545 | Ø8.5x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5030 | Ø5.0x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8515 | Ø8.5x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1505 | Ø10.5x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7045 | Ø7.0x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8015 | Ø8.0x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6095 | Ø6.0x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9585 | Ø9.5x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7560 | Ø7.5x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7025 | Ø7.0x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7575 | Ø7.5x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5050 | Short Cannulated Tap, Ø5.0mm | In distribution |
| 824M5525 | Ø5.5x25mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8550 | Ø8.5x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1575 | Ø10.5x75mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5545 | Ø5.5x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1560 | Ø10.5x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8585 | Ø8.5x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M4535 | Ø4.5x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9530 | Ø9.5x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5585 | Ø5.5x85mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8510 | Ø8.5x110mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6521 | Ø6.5x120mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6545 | Ø6.5x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8065 | Ø8.0x65mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6590 | Ø6.5x90mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7020 | Ø7.0x20mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7050 | Ø7.0x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9565 | Ø9.5x65mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8010 | Ø8.0x110mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9015 | Ø9.0x115mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1580 | Ø10.5x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5555 | Ø5.5x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9505 | Ø9.5x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9060 | Ø9.0x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5535 | Ø5.5x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6035 | Ø6.0x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9510 | Ø9.5x110mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8535 | Ø8.5x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8595 | Ø8.5x95mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M7545 | Ø7.5x45mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1090 | Ø10.0x90mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 850M5040 | Short Cannulated Tap, Ø4.0mm | In distribution |
| 824M4540 | Ø4.5x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9535 | Ø9.5x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9035 | Ø9.0x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M4530 | Ø4.5x30mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1535 | Ø10.5x35mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9550 | Ø9.5x50mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M5540 | Ø5.5x40mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M9560 | Ø9.5x60mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1055 | Ø10.0x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M8055 | Ø8.0x55mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 825M1080 | Ø10.0x80mm Cannulated Polyaxial Extended Tab Screw | In distribution |
| 824M6505 | Ø6.5x105mm Cannulated Polyaxial Extended Tab Screw | In distribution |
Showing 250 of 265 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151974 | 2015-11-13 |
| K141804 | 2014-09-25 |
| K121130 | 2012-06-15 |
| K091067 | 2009-07-14 |
| K081952 | 2008-10-07 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-03-12 | Class II | Nonconforming Material/Component | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. | 4,765 units | 2015-12-21 |
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.