Silverton-D Deformity System
247 catalogue numbers from 7722-8570, 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
247catalogue 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 | 2015-10-24 |
| 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 |
|---|---|---|
| 7722-8570 | SCREW MONO OSTEO TI Ø8.5X70MM | In distribution |
| 7722-0530 | SCREW MONO OSTEO TI Ø10.5X30MM | In distribution |
| 7718-5565 | SCREW ASSY OSTEO REDUCTION TI Ø5.5X65MM | In distribution |
| 7718-6525 | SCREW ASSY OSTEO REDUCTION TI Ø6.5X25MM | In distribution |
| 7736-0525 | Screw Assy Turret Osteo Red TiØ10.5x25mm | In distribution |
| 7736-8535 | SCREW ASSY TURRET OSTEO RED TI Ø8.5X35MM | In distribution |
| 7733-6565 | PEDICLE SCREW RED TURRET TI Ø6.5X65MM | In distribution |
| 7702-6010 | OPEN OFFSET CONNECTOR TI 15° RIGHT 10MM | In distribution |
| 7717-9545 | PEDICLE SCREW MONOAXIAL TI Ø9.5X45MM | In distribution |
| 7733-5525 | Pedicle Screw Red Turret Ti Ø5.5x25mm | In distribution |
| 7733-7575 | PEDICLE SCREW RED TURRET TI Ø7.5X75MM | In distribution |
| 7736-7585 | SCREW ASSY TURRET OSTEO RED TI Ø7.5X85MM | In distribution |
| 7733-7560 | Pedicle Screw Red Turret Ti Ø7.5x60mm | In distribution |
| 7702-4202 | Connector Parallel Extended Ti 2×2 | In distribution |
| 7736-6545 | SCREW ASSY TURRET OSTEO RED TI Ø6.5X45MM | In distribution |
| 7733-7555 | Pedicle Screw Red Turret Ti Ø7.5x55mm | In distribution |
| 7720-0708 | HOOK LAMINAR WIDE BLADE TI SM | In distribution |
| 7717-7530 | Pedicle Screw Monoaxial Ti Ø7.5x30mm | In distribution |
| 7722-0555 | Screw Mono Osteo Ti Ø10.5x55mm | In distribution |
| 7736-8595 | Screw Assy Turret Osteo Red Ti Ø8.5x95mm | In distribution |
| 7733-4580 | Pedicle Screw Red Turret Ti Ø4.5x80mm | In distribution |
| 7733-7565 | PEDICLE SCREW RED TURRET TI Ø7.5X65MM | In distribution |
| 7718-7565 | SCREW ASSY OSTEO REDUCTION TI Ø7.5X65MM | In distribution |
| 7717-7555 | PEDICLE SCREW MONOAXIAL TI Ø7.5X55MM | In distribution |
| 7722-6590 | Screw Mono Osteo Ti Ø6.5x90mm | In distribution |
| 7717-4525 | Pedicle Screw Monoaxial Ti Ø4.5x25mm | In distribution |
| 7719-7535 | PEDICLE SCREW REDUCTION TI Ø7.5X35MM | In distribution |
| 7736-9535 | Screw Assy Turret Osteo Red Ti Ø9.5x35mm | In distribution |
| 7736-9550 | Screw Assy Turret Osteo Red Ti Ø9.5x50mm | In distribution |
| 7717-0500 | PEDICLE SCREW MONOAXIAL TI Ø10.5X100MM | In distribution |
| 7718-8535 | Screw Assy Osteo Reduction Ti Ø8.5x35mm | In distribution |
| 7718-5575 | Screw Assy Osteo Reduction Ti Ø5.5x75mm | In distribution |
| 7702-4202 | CONNECTOR PARALLEL EXTENDED TI 2X2 | In distribution |
| 7722-9525 | SCREW MONO OSTEO TI Ø9.5X25MM | In distribution |
| 7736-6540 | Screw Assy Turret Osteo Red Ti Ø6.5x40mm | In distribution |
| 7722-0560 | Screw Mono Osteo Ti Ø10.5x60mm | In distribution |
| 7717-9565 | PEDICLE SCREW MONOAXIAL TI Ø9.5X65MM | In distribution |
| 7736-5575 | SCREW ASSY TURRET OSTEO RED TI Ø5.5X75MM | In distribution |
| 7702-3015 | CONNECTOR OFFSET OPEN TI 15MM | In distribution |
| 7722-9500 | SCREW MONO OSTEO TI Ø9.5X100MM | In distribution |
| 7736-6530 | SCREW ASSY TURRET OSTEO RED TI Ø6.5X30MM | In distribution |
| 7722-6580 | Screw Mono Osteo Ti Ø6.5x80mm | In distribution |
| 7719-6535 | PEDICLE SCREW REDUCTION TI Ø6.5X35MM | In distribution |
| 7717-0585 | Pedicle Screw Monoaxial Ti Ø10.5x85mm | In distribution |
| 7736-7535 | Screw Assy Turret Osteo Red Ti Ø7.5x35mm | In distribution |
| 7736-6590 | Screw Assy Turret Osteo Red Ti Ø6.5x90mm | In distribution |
| 7736-5590 | SCREW ASSY TURRET OSTEO RED TI Ø5.5X90MM | In distribution |
| 7717-8530 | PEDICLE SCREW MONOAXIAL TI Ø8.5X30MM | In distribution |
| 7722-9580 | Screw Mono Osteo Ti Ø9.5x80mm | In distribution |
| 7717-4585 | PEDICLE SCREW MONOAXIAL TI Ø4.5X85MM | In distribution |
| 7733-6580 | Pedicle Screw Red Turret Ti Ø6.5x80mm | In distribution |
| 7736-5550 | Screw Assy Turret Osteo Red Ti Ø5.5x45mm | In distribution |
| 7722-9540 | Screw Mono Osteo Ti Ø9.5x40mm | In distribution |
| 7722-7560 | SCREW MONO OSTEO TI Ø7.5X60MM | In distribution |
| 7718-5545 | SCREW ASSY OSTEO REDUCTION TI Ø5.5X45MM | In distribution |
| 7722-9550 | Screw Mono Osteo Ti Ø9.5x50mm | In distribution |
| 7718-5520 | Screw Assy Osteo Reduction Ti Ø5.5x20mm | In distribution |
| 7733-6540 | Pedicle Screw Red Turret Ti Ø6.5x40mm | In distribution |
| 7717-6550 | Pedicle Screw Monoaxial Ti Ø6.5x50mm | In distribution |
| 7717-4545 | Pedicle Screw Monoaxial Ti Ø4.5x45mm | In distribution |
| 7718-6555 | Screw Assy Osteo Reduction Ti Ø6.5x55mm | In distribution |
| 7718-8530 | Screw Assy Osteo Reduction Ti Ø8.5x30mm | In distribution |
| 7736-9565 | Screw Assy Turret Osteo Red Ti Ø9.5x65mm | In distribution |
| 7722-8540 | SCREW MONO OSTEO TI Ø8.5X40MM | In distribution |
| 7736-5575 | Screw Assy Turret Osteo Red Ti Ø5.5x75mm | In distribution |
| 7717-0520 | PEDICLE SCREW MONOAXIAL TI Ø10.5X20MM | In distribution |
| 7722-6500 | SCREW MONO OSTEO TI Ø6.5X100MM | In distribution |
| 7702-3025 | CONNECTOR OFFSET OPEN TI 25MM | In distribution |
| 7736-5565 | Screw Assy Turret Osteo Red Ti Ø5.5x65mm | In distribution |
| 7736-9535 | SCREW ASSY TURRET OSTEO RED TI Ø9.5X35MM | In distribution |
| 7733-6535 | PEDICLE SCREW RED TURRET TI Ø6.5X35MM | In distribution |
| 7717-9555 | PEDICLE SCREW MONOAXIAL TI Ø9.5X55MM | In distribution |
| 7736-9590 | Screw Assy Turret Osteo Red Ti Ø9.5x90mm | In distribution |
| 7722-5580 | SCREW MONO OSTEO TI Ø5.5X80MM | In distribution |
| 7733-8595 | Pedicle Screw Red Turret Ti Ø8.5x95mm | In distribution |
| 7736-9555 | SCREW ASSY TURRET OSTEO RED TI Ø9.5X55MM | In distribution |
| 7733-6500 | PEDICLE SCREW RED TURRET TI Ø6.5X100MM | In distribution |
| 7717-0540 | Pedicle Screw Monoaxial Ti Ø10.5x40mm | In distribution |
| 7722-7590 | SCREW MONO OSTEO TI Ø7.5X90MM | In distribution |
| 7736-7580 | SCREW ASSY TURRET OSTEO RED TI Ø7.5X80MM | In distribution |
| 7736-7535 | SCREW ASSY TURRET OSTEO RED TI Ø7.5X35MM | In distribution |
| 7736-6525 | SCREW ASSY TURRET OSTEO RED TI Ø6.5X25MM | In distribution |
| 7717-9560 | Pedicle Screw Monoaxial Ti Ø9.5x60mm | In distribution |
| 7717-5535 | PEDICLE SCREW MONOAXIAL TI Ø5.5X35MM | In distribution |
| 7736-8535 | Screw Assy Turret Osteo Red Ti Ø8.5x35mm | In distribution |
| 7718-5570 | Screw Assy Osteo Reduction Ti Ø5.5x70mm | In distribution |
| 7722-8540 | Screw Mono Osteo Ti Ø8.5x40mm | In distribution |
| 7717-9565 | Pedicle Screw Monoaxial Ti Ø9.5x65mm | In distribution |
| 7723-0508 | Hook Ramped Blade Deformity Ti | In distribution |
| 7722-0550 | Screw Mono Osteo Ti Ø10.5x50mm | In distribution |
| 7702-6140 | Open Offset Connector Ti 15° Left 40mm | In distribution |
| 7733-7545 | PEDICLE SCREW RED TURRET TI Ø7.5X45MM | In distribution |
| 7736-6575 | SCREW ASSY TURRET OSTEO RED TI Ø6.5X75MM | In distribution |
| 7718-5560 | SCREW ASSY OSTEO REDUCTION TI Ø5.5X60MM | In distribution |
| 7733-5500 | PEDICLE SCREW RED TURRET TI Ø5.5X100MM | In distribution |
| 7722-9575 | Screw Mono Osteo Ti Ø9.5x75mm | In distribution |
| 7733-4540 | Pedicle Screw Red Turret Ti Ø4.5x40mm | In distribution |
| 7733-4535 | PEDICLE SCREW RED TURRET TI Ø4.5X35MM | In distribution |
| 7717-4540 | PEDICLE SCREW MONOAXIAL TI Ø4.5X40MM | In distribution |
| 7736-8575 | SCREW ASSY TURRET OSTEO RED TI Ø8.5X75MM | In distribution |
| 7718-8585 | SCREW ASSY OSTEO REDUCTION TI Ø8.5X85MM | In distribution |
| 7736-9570 | Screw Assy Turret Osteo Red Ti Ø9.5x70mm | In distribution |
| 7736-5500 | Screw Assy Turret Osteo Red TiØ5.5x100mm | In distribution |
| 7717-9595 | PEDICLE SCREW MONOAXIAL TI Ø9.5X95MM | In distribution |
| 7722-8595 | Screw Mono Osteo Ti Ø8.5x95mm | In distribution |
| 7736-9595 | Screw Assy Turret Osteo Red Ti Ø9.5x95mm | In distribution |
| 7717-4500 | Pedicle Screw Monoaxial Ti Ø4.5x100mm | In distribution |
| 7717-0580 | PEDICLE SCREW MONOAXIAL TI Ø10.5X80MM | In distribution |
| 7722-6545 | SCREW MONO OSTEO TI Ø6.5X45MM | In distribution |
| 7722-8555 | Screw Mono Osteo Ti Ø8.5x55mm | In distribution |
| 7717-0570 | Pedicle Screw Monoaxial Ti Ø10.5x70mm | In distribution |
| 7733-8500 | PEDICLE SCREW RED TURRET TI Ø8.5X100MM | In distribution |
| 7718-5500 | SCREW ASSY OSTEO REDUCTION TI Ø5.5X100MM | In distribution |
| 7736-9575 | Screw Assy Turret Osteo Red Ti Ø9.5x75mm | In distribution |
| 7736-5560 | SCREW ASSY TURRET OSTEO RED TI Ø5.5X60MM | In distribution |
| 7702-4201 | Connector Parallel Standard Ti 2×2 | In distribution |
| 7722-0550 | SCREW MONO OSTEO TI Ø10.5X50MM | In distribution |
| 7718-5585 | Screw Assy Osteo Reduction Ti Ø5.5x85mm | In distribution |
| 7702-4201 | CONNECTOR PARALLEL STANDARD TI 2X2 | In distribution |
| 7733-5555 | PEDICLE SCREW RED TURRET TI Ø5.5X55MM | In distribution |
| 7722-0535 | Screw Mono Osteo Ti Ø10.5x35mm | In distribution |
| 7733-4565 | PEDICLE SCREW RED TURRET TI Ø4.5X65MM | In distribution |
| 7736-0595 | Screw Assy Turret Osteo Red TiØ10.5x95mm | In distribution |
| 7736-9500 | SCREW ASSY TURRET OSTEO RED TIØ9.5X100MM | In distribution |
| 7733-8560 | PEDICLE SCREW RED TURRET TI Ø8.5X60MM | In distribution |
| 7718-6540 | SCREW ASSY OSTEO REDUCTION TI Ø6.5X40MM | In distribution |
| 7719-5550 | PEDICLE SCREW REDUCTION TI Ø5.5X50MM | In distribution |
| 7717-7530 | PEDICLE SCREW MONOAXIAL TI Ø7.5X30MM | In distribution |
| 7718-6555 | SCREW ASSY OSTEO REDUCTION TI Ø6.5X55MM | In distribution |
| 7719-7545 | Pedicle Screw Reduction Ti Ø7.5x45mm | In distribution |
| 7717-8535 | PEDICLE SCREW MONOAXIAL TI Ø8.5X35MM | In distribution |
| 7733-5575 | PEDICLE SCREW RED TURRET TI Ø5.5X75MM | In distribution |
| 7722-0595 | SCREW MONO OSTEO TI Ø10.5X95MM | In distribution |
| 7733-5560 | PEDICLE SCREW RED TURRET TI Ø5.5X60MM | In distribution |
| 7718-7540 | SCREW ASSY OSTEO REDUCTION TI Ø7.5X40MM | In distribution |
| 7736-5540 | Screw Assy Turret Osteo Red Ti Ø5.5x40mm | In distribution |
| 7719-7550 | Pedicle Screw Reduction Ti Ø7.5x50mm | In distribution |
| 7717-0530 | Pedicle Screw Monoaxial Ti Ø10.5x30mm | In distribution |
| 7722-8530 | SCREW MONO OSTEO TI Ø8.5X30MM | In distribution |
| 7722-6555 | SCREW MONO OSTEO TI Ø6.5X55MM | In distribution |
| 7722-5520 | Screw Mono Osteo Ti Ø5.5x20mm | In distribution |
| 7702-3025 | Connector Offset Open Ti 25mm | In distribution |
| 7718-5530 | Screw Assy Osteo Reduction Ti Ø5.5x30mm | In distribution |
| 7736-8500 | SCREW ASSY TURRET OSTEO RED TIØ8.5X100MM | In distribution |
| 7717-8540 | Pedicle Screw Monoaxial Ti Ø8.5x40mm | In distribution |
| 7717-6555 | Pedicle Screw Monoaxial Ti Ø6.5x55mm | In distribution |
| 7725-4507 | Hook Angled Deformity Ti Right | In distribution |
| 7718-8545 | Screw Assy Osteo Reduction Ti Ø8.5x45mm | In distribution |
| 7702-6150 | OPEN OFFSET CONNECTOR TI 15° LEFT 50MM | In distribution |
| 7733-8565 | PEDICLE SCREW RED TURRET TI Ø8.5X65MM | In distribution |
| 7736-0580 | Screw Assy Turret Osteo Red TiØ10.5x80mm | In distribution |
| 7736-0575 | Screw Assy Turret Osteo Red TiØ10.5x75mm | In distribution |
| 7733-4560 | PEDICLE SCREW RED TURRET TI Ø4.5X60MM | In distribution |
| 7718-6500 | Screw Assy Osteo Reduction Ti Ø6.5x100mm | In distribution |
| 7718-8525 | SCREW ASSY OSTEO REDUCTION TI Ø8.5X25MM | In distribution |
| 7733-5530 | PEDICLE SCREW RED TURRET TI Ø5.5X30MM | In distribution |
| 7717-8580 | PEDICLE SCREW MONOAXIAL TI Ø8.5X80MM | In distribution |
| 7733-8570 | Pedicle Screw Red Turret Ti Ø8.5x70mm | In distribution |
| 7719-7545 | PEDICLE SCREW REDUCTION TI Ø7.5X45MM | In distribution |
| 7702-6025 | OPEN OFFSET CONNECTOR TI 15° RIGHT 25MM | In distribution |
| 7719-5540 | Pedicle Screw Reduction Ti Ø5.5x40mm | In distribution |
| 7717-4575 | PEDICLE SCREW MONOAXIAL TI Ø4.5X75MM | In distribution |
| 7722-5535 | SCREW MONO OSTEO TI Ø5.5X35MM | In distribution |
| 7717-4555 | PEDICLE SCREW MONOAXIAL TI Ø4.5X55MM | In distribution |
| 7733-7595 | Pedicle Screw Red Turret Ti Ø7.5x95mm | In distribution |
| 7718-5500 | Screw Assy Osteo Reduction Ti Ø5.5x100mm | In distribution |
| 7733-6580 | PEDICLE SCREW RED TURRET TI Ø6.5X80MM | In distribution |
| 7717-9585 | PEDICLE SCREW MONOAXIAL TI Ø9.5X85MM | In distribution |
| 7736-7540 | SCREW ASSY TURRET OSTEO RED TI Ø7.5X40MM | In distribution |
| 7718-8590 | Screw Assy Osteo Reduction Ti Ø8.5x90mm | In distribution |
| 7717-8545 | PEDICLE SCREW MONOAXIAL TI Ø8.5X45MM | In distribution |
| 7717-6535 | PEDICLE SCREW MONOAXIAL TI Ø6.5X35MM | In distribution |
| 7722-6545 | Screw Mono Osteo Ti Ø6.5x45mm | In distribution |
| 7722-7580 | Screw Mono Osteo Ti Ø7.5x80mm | In distribution |
| 7736-5545 | SCREW ASSY TURRET OSTEO RED TI Ø5.5X45MM | In distribution |
| 7733-8555 | PEDICLE SCREW RED TURRET TI Ø8.5X55MM | In distribution |
| 7717-8500 | Pedicle Screw Monoaxial Ti Ø8.5x100mm | In distribution |
| 7721-0909 | HOOK PEDICLE TI LRG | In distribution |
| 7722-6530 | SCREW MONO OSTEO TI Ø6.5X30MM | In distribution |
| 7733-6560 | PEDICLE SCREW RED TURRET TI Ø6.5X60MM | In distribution |
| 7719-7535 | Pedicle Screw Reduction Ti Ø7.5x35mm | In distribution |
| 7722-0545 | SCREW MONO OSTEO TI Ø10.5X45MM | In distribution |
| 7717-9540 | PEDICLE SCREW MONOAXIAL TI Ø9.5X40MM | In distribution |
| 7736-6500 | Screw Assy Turret Osteo Red TiØ6.5x100mm | In distribution |
| 7736-8525 | SCREW ASSY TURRET OSTEO RED TI Ø8.5X25MM | In distribution |
| 7722-7525 | SCREW MONO OSTEO TI Ø7.5X25MM | In distribution |
| 7721-0707 | Hook Pedicle Ti Sm | In distribution |
| 7736-5530 | Screw Assy Turret Osteo Red Ti Ø5.5x30mm | In distribution |
| 7717-6525 | Pedicle Screw Monoaxial Ti Ø6.5x25mm | In distribution |
| 7718-8560 | SCREW ASSY OSTEO REDUCTION TI Ø8.5X60MM | In distribution |
| 7722-9525 | Screw Mono Osteo Ti Ø9.5x25mm | In distribution |
| 7722-5540 | SCREW MONO OSTEO TI Ø5.5X40MM | In distribution |
| 7722-5555 | Screw Mono Osteo Ti Ø5.5x55mm | In distribution |
| 7733-4595 | Pedicle Screw Red Turret Ti Ø4.5x95mm | In distribution |
| 7736-6550 | Screw Assy Turret Osteo Red Ti Ø6.5x45mm | In distribution |
| 7722-6550 | Screw Mono Osteo Ti Ø6.5x50mm | In distribution |
| 7717-6555 | PEDICLE SCREW MONOAXIAL TI Ø6.5X55MM | In distribution |
| 7722-0590 | SCREW MONO OSTEO TI Ø10.5X90MM | In distribution |
| 7736-0500 | Screw Assy Turret Osteo RedTiØ10.5x100mm | In distribution |
| 7717-8550 | Pedicle Screw Monoaxial Ti Ø8.5x50mm | In distribution |
| 7733-6540 | PEDICLE SCREW RED TURRET TI Ø6.5X40MM | In distribution |
| 7733-5535 | Pedicle Screw Red Turret Ti Ø5.5x35mm | In distribution |
| 7736-9560 | SCREW ASSY TURRET OSTEO RED TI Ø9.5X60MM | In distribution |
| 7718-6585 | SCREW ASSY OSTEO REDUCTION TI Ø6.5X85MM | In distribution |
| 7722-9545 | SCREW MONO OSTEO TI Ø9.5X45MM | In distribution |
| 7718-8575 | Screw Assy Osteo Reduction Ti Ø8.5x75mm | In distribution |
| 7736-7545 | Screw Assy Turret Osteo Red Ti Ø7.5x45mm | In distribution |
| 7736-0550 | Screw Assy Turret Osteo Red TiØ10.5x50mm | In distribution |
| 7722-9545 | Screw Mono Osteo Ti Ø9.5x45mm | In distribution |
| 7733-5550 | PEDICLE SCREW RED TURRET TI Ø5.5X50MM | In distribution |
| 7736-8530 | SCREW ASSY TURRET OSTEO RED TI Ø8.5X30MM | In distribution |
| 7733-7595 | PEDICLE SCREW RED TURRET TI Ø7.5X95MM | In distribution |
| 7717-0535 | Pedicle Screw Monoaxial Ti Ø10.5x35mm | In distribution |
| 7722-0590 | Screw Mono Osteo Ti Ø10.5x90mm | In distribution |
| 7722-0540 | SCREW MONO OSTEO TI Ø10.5X40MM | In distribution |
| 7733-6590 | Pedicle Screw Red Turret Ti Ø6.5x90mm | In distribution |
| 7718-6565 | SCREW ASSY OSTEO REDUCTION TI Ø6.5X65MM | In distribution |
| 7722-8525 | Screw Mono Osteo Ti Ø8.5x25mm | In distribution |
| 7719-5545 | PEDICLE SCREW REDUCTION TI Ø5.5X45MM | In distribution |
| 7733-8580 | PEDICLE SCREW RED TURRET TI Ø8.5X80MM | In distribution |
| 7717-6550 | PEDICLE SCREW MONOAXIAL TI Ø6.5X50MM | In distribution |
| 7733-7540 | Pedicle Screw Red Turret Ti Ø7.5x40mm | In distribution |
| 7719-5535 | PEDICLE SCREW REDUCTION TI Ø5.5X35MM | In distribution |
| 7733-5580 | Pedicle Screw Red Turret Ti Ø5.5x80mm | In distribution |
| 7702-6110 | OPEN OFFSET CONNECTOR TI 15° LEFT 10MM | In distribution |
| 7736-6540 | SCREW ASSY TURRET OSTEO RED TI Ø6.5X40MM | In distribution |
| 7702-3140 | CONNECTOR OFFSET CLOSED TI 40MM | In distribution |
| 7717-8580 | Pedicle Screw Monoaxial Ti Ø8.5x80mm | In distribution |
| 7702-6125 | OPEN OFFSET CONNECTOR TI 15° LEFT 25MM | In distribution |
| 7718-6590 | Screw Assy Osteo Reduction Ti Ø6.5x90mm | In distribution |
| 7733-5580 | PEDICLE SCREW RED TURRET TI Ø5.5X80MM | In distribution |
| 7718-8540 | Screw Assy Osteo Reduction Ti Ø8.5x40mm | In distribution |
| 7722-7520 | Screw Mono Osteo Ti Ø7.5x20mm | In distribution |
| 7722-8525 | SCREW MONO OSTEO TI Ø8.5X25MM | In distribution |
| 7733-4545 | PEDICLE SCREW RED TURRET TI Ø4.5X45MM | In distribution |
| 7722-7545 | Screw Mono Osteo Ti Ø7.5x45mm | In distribution |
| 7733-6570 | Pedicle Screw Red Turret Ti Ø6.5x70mm | In distribution |
| 7722-8575 | SCREW MONO OSTEO TI Ø8.5X75MM | In distribution |
| 7722-6595 | Screw Mono Osteo Ti Ø6.5x95mm | In distribution |
| 7722-9520 | Screw Mono Osteo Ti Ø9.5x20mm | In distribution |
| 7722-9555 | Screw Mono Osteo Ti Ø9.5x55mm | In distribution |
| 7717-7540 | PEDICLE SCREW MONOAXIAL TI Ø7.5X40MM | In distribution |
| 7717-4550 | PEDICLE SCREW MONOAXIAL TI Ø4.5X50MM | In distribution |
| 7736-0500 | SCREW ASSY TURRET OSTEO REDTIØ10.5X100MM | In distribution |
| 7736-7575 | SCREW ASSY TURRET OSTEO RED TI Ø7.5X75MM | In distribution |
| 7717-6530 | PEDICLE SCREW MONOAXIAL TI Ø6.5X30MM | In distribution |
| 7722-0585 | SCREW MONO OSTEO TI Ø10.5X85MM | In distribution |
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| 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.