Telluride® MIS Spinal Fixation System
123 catalogue numbers from 7728-9565, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
123catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2020-06-27 |
| 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 |
|---|---|---|
| 7728-9565 | Ø9.5 X 65mm Cann Mono Ped Screw | In distribution |
| 7729-6545 | Screw Assy Cann Osteo Ti Ø6.5x45mm | In distribution |
| 7716-8525 | Pedicle Screw Cannulated Ti Ø8.5x25mm | In distribution |
| 7711-0200 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X200 | In distribution |
| 7728-6540 | Ø6.5 X 40mm Cann Mono Ped Screw | In distribution |
| 7723-8520 | SCREW CANN MONO OSTEO TI Ø8.5X20MM | In distribution |
| 7728-8555 | Ø8.5 X 55MM CANN MONO PED SCREW | In distribution |
| 7716-8540 | Pedicle Screw Cannulated Ti Ø8.5x40mm | In distribution |
| 7728-9565 | Ø9.5 X 65MM CANN MONO PED SCREW | In distribution |
| 7728-8520 | Ø8.5 X 20MM CANN MONO PED SCREW | In distribution |
| 7716-6520 | PEDICLE SCREW CANNULATED TI Ø6.5X20MM | In distribution |
| 7723-5570 | SCREW CANN MONO OSTEO TI Ø5.5X70MM | In distribution |
| 7728-0520 | Ø10.5 x 20mm Cann Mono Ti Ped Screw | In distribution |
| 7716-5525 | PEDICLE SCREW CANNULATED TI Ø5.5X25MM | In distribution |
| 7711-0035 | Rod Percutaneous Straight Ti ø5.5×35 | In distribution |
| 7729-7545 | SCREW ASSY CANN OSTEO TI Ø7.5X45MM | In distribution |
| 7728-0565 | Ø10.5 x 65mm Cann Mono Ti Ped Screw | In distribution |
| 7716-6560 | Pedicle Screw Cannulated Ti Ø6.5x60mm | In distribution |
| 7729-6555 | Screw Assy Cann Osteo Ti Ø6.5x55mm | In distribution |
| 7728-0560 | Ø10.5 X 60MM CANN MONO TI PED SCREW | In distribution |
| 7711-0080 | Rod Percutaneous Straight Ti ø5.5×80 | In distribution |
| 7723-7540 | Screw Cann Mono Osteo Ti Ø7.5x40mm | In distribution |
| 7729-8565 | SCREW ASSY CANN OSTEO TI Ø8.5X65MM | In distribution |
| 7711-1055 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X55 | In distribution |
| 7728-6545 | Ø6.5 X 45mm Cann Mono Ped Screw | In distribution |
| 7729-5530 | Screw Assy Cann Osteo Ti Ø5.5x30mm | In distribution |
| 7728-9530 | Ø9.5 X 30mm Cann Mono Ped Screw | In distribution |
| 7716-5530 | Pedicle Screw Cannulated Ti Ø5.5x30mm | In distribution |
| 7711-1030 | Rod Percutaneous Med Curved Ti ø5.5×30 | In distribution |
| 7728-8540 | Ø8.5 X 40MM CANN MONO PED SCREW | In distribution |
| 7729-5550 | Screw Assy Cann Osteo Ti Ø5.5x50mm | In distribution |
| 7723-8545 | Screw Cann Mono Osteo Ti Ø8.5x45mm | In distribution |
| 7728-0550 | Ø10.5 X 50MM CANN MONO TI PED SCREW | In distribution |
| 7716-8530 | Pedicle Screw Cannulated Ti Ø8.5x30mm | In distribution |
| 7728-7520 | Ø7.5 X 20MM CANN MONO PED SCREW | In distribution |
| 7716-8545 | Pedicle Screw Cannulated Ti Ø8.5x45mm | In distribution |
| 7723-0560 | SCREW CANN MONO OSTEO TI Ø10.5X60MM | In distribution |
| 7729-5540 | SCREW ASSY CANN OSTEO TI Ø5.5X40MM | In distribution |
| 7723-0540 | Screw Cann Mono Osteo Ti Ø10.5x40mm | In distribution |
| 7716-6530 | Pedicle Screw Cannulated Ti Ø6.5x30mm | In distribution |
| 7729-6540 | SCREW ASSY CANN OSTEO TI Ø6.5X40MM | In distribution |
| 7711-0600 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X600 | In distribution |
| 7716-7565 | PEDICLE SCREW CANNULATED TI Ø7.5X65MM | In distribution |
| 7728-8560 | Ø8.5 X 60mm Cann Mono Ped Screw | In distribution |
| 7723-0550 | SCREW CANN MONO OSTEO TI Ø10.5X50MM | In distribution |
| 7729-7525 | Screw Assy Cann Osteo Ti Ø7.5x25mm | In distribution |
| 7723-8560 | Screw Cann Mono Osteo Ti Ø8.5x60mm | In distribution |
| 7723-9555 | Screw Cann Mono Osteo Ti Ø9.5x55mm | In distribution |
| 7716-8570 | PEDICLE SCREW CANNULATED TI Ø8.5X70MM | In distribution |
| 7728-6565 | Ø6.5 X 65mm Cann Mono Ped Screw | In distribution |
| 7716-7520 | PEDICLE SCREW CANNULATED TI Ø7.5X20MM | In distribution |
| 7723-0550 | Screw Cann Mono Osteo Ti Ø10.5x50mm | In distribution |
| 7723-9530 | Screw Cann Mono Osteo Ti Ø9.5x30mm | In distribution |
| 7711-0055 | Rod Percutaneous Straight Ti ø5.5×55 | In distribution |
| 7711-1115 | Rod Percutaneous Med Curved Ti ø5.5×115 | In distribution |
| 7728-8550 | Ø8.5 X 50mm Cann Mono Ped Screw | In distribution |
| 7728-5555 | Ø5.5 X 55mm Cann Mono Ped Screw | In distribution |
| 7728-0525 | Ø10.5 X 25MM CANN MONO TI PED SCREW | In distribution |
| 7711-0300 | Rod Percutaneous Straight Ti ø5.5×300 | In distribution |
| 7728-9560 | Ø9.5 X 60mm Cann Mono Ped Screw | In distribution |
| 7711-0115 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X115 | In distribution |
| 7728-9525 | Ø9.5 X 25mm Cann Mono Ped Screw | In distribution |
| 7716-8555 | PEDICLE SCREW CANNULATED TI Ø8.5X55MM | In distribution |
| 7723-7570 | SCREW CANN MONO OSTEO TI Ø7.5X70MM | In distribution |
| 7711-0045 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X45 | In distribution |
| 7729-7535 | Screw Assy Cann Osteo Ti Ø7.5x35mm | In distribution |
| 7728-7545 | Ø7.5 X 45mm Cann Mono Ped Screw | In distribution |
| 7716-6550 | Pedicle Screw Cannulated Ti Ø6.5x50mm | In distribution |
| 7711-1055 | Rod Percutaneous Med Curved Ti ø5.5×55 | In distribution |
| 7728-7570 | Ø7.5 X 70MM CANN MONO PED SCREW | In distribution |
| 7723-5570 | Screw Cann Mono Osteo Ti Ø5.5x70mm | In distribution |
| 7729-6520 | Screw Assy Cann Osteo Ti Ø6.5x20mm | In distribution |
| 7729-5530 | SCREW ASSY CANN OSTEO TI Ø5.5X30MM | In distribution |
| 7723-8570 | Screw Cann Mono Osteo Ti Ø8.5x70mm | In distribution |
| 7728-7570 | Ø7.5 X 70mm Cann Mono Ped Screw | In distribution |
| 7711-0020 | Rod Percutaneous Straight Ti ø5.5×20 | In distribution |
| 7728-8520 | Ø8.5 X 20mm Cann Mono Ped Screw | In distribution |
| 7723-6570 | Screw Cann Mono Osteo Ti Ø6.5x70mm | In distribution |
| 7723-8525 | Screw Cann Mono Osteo Ti Ø8.5x25mm | In distribution |
| 7728-8525 | Ø8.5 X 25mm Cann Mono Ped Screw | In distribution |
| 7716-8535 | Pedicle Screw Cannulated Ti Ø8.5x35mm | In distribution |
| 7723-9520 | Screw Cann Mono Osteo Ti Ø9.5x20mm | In distribution |
| 7711-1120 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X120 | In distribution |
| 7711-1110 | Rod Percutaneous Med Curved Ti ø5.5×110 | In distribution |
| 7716-7535 | PEDICLE SCREW CANNULATED TI Ø7.5X35MM | In distribution |
| 7728-0530 | Ø10.5 X 30MM CANN MONO TI PED SCREW | In distribution |
| 7716-7545 | PEDICLE SCREW CANNULATED TI Ø7.5X45MM | In distribution |
| 7711-1105 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X105 | In distribution |
| 7716-6540 | PEDICLE SCREW CANNULATED TI Ø6.5X40MM | In distribution |
| 7728-8555 | Ø8.5 X 55mm Cann Mono Ped Screw | In distribution |
| 7729-7565 | SCREW ASSY CANN OSTEO TI Ø7.5X65MM | In distribution |
| 7723-8545 | SCREW CANN MONO OSTEO TI Ø8.5X45MM | In distribution |
| 7728-0560 | Ø10.5 x 60mm Cann Mono Ti Ped Screw | In distribution |
| 7716-5540 | PEDICLE SCREW CANNULATED TI Ø5.5X40MM | In distribution |
| 7729-5565 | Screw Assy Cann Osteo Ti Ø5.5x65mm | In distribution |
| 7723-8555 | SCREW CANN MONO OSTEO TI Ø8.5X55MM | In distribution |
| 7716-5540 | Pedicle Screw Cannulated Ti Ø5.5x40mm | In distribution |
| 7729-8555 | Screw Assy Cann Osteo Ti Ø8.5x55mm | In distribution |
| 7711-1120 | Rod Percutaneous Med Curved Ti ø5.5×120 | In distribution |
| 7729-8540 | Screw Assy Cann Osteo Ti Ø8.5x40mm | In distribution |
| 7728-8570 | Ø8.5 X 70MM CANN MONO PED SCREW | In distribution |
| 7723-7555 | Screw Cann Mono Osteo Ti Ø7.5x55mm | In distribution |
| 7728-0555 | Ø10.5 X 55MM CANN MONO TI PED SCREW | In distribution |
| 7729-7555 | SCREW ASSY CANN OSTEO TI Ø7.5X55MM | In distribution |
| 7716-8530 | PEDICLE SCREW CANNULATED TI Ø8.5X30MM | In distribution |
| 7729-6525 | Screw Assy Cann Osteo Ti Ø6.5x25mm | In distribution |
| 7711-0140 | Rod Percutaneous Straight Ti ø5.5×140 | In distribution |
| 7711-0170 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X170 | In distribution |
| 7728-9535 | Ø9.5 X 35MM CANN MONO PED SCREW | In distribution |
| 7723-5540 | Screw Cann Mono Osteo Ti Ø5.5x40mm | In distribution |
| 7729-8520 | Screw Assy Cann Osteo Ti Ø8.5x20mm | In distribution |
| 7728-0570 | Ø10.5 x 70mm Cann Mono Ti Ped Screw | In distribution |
| 7711-0150 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X150 | In distribution |
| 7723-0535 | SCREW CANN MONO OSTEO TI Ø10.5X35MM | In distribution |
| 7716-6530 | PEDICLE SCREW CANNULATED TI Ø6.5X30MM | In distribution |
| 7729-5555 | Screw Assy Cann Osteo Ti Ø5.5x55mm | In distribution |
| 7729-8560 | Screw Assy Cann Osteo Ti Ø8.5x60mm | In distribution |
| 7729-6565 | SCREW ASSY CANN OSTEO TI Ø6.5X65MM | In distribution |
| 7716-8570 | Pedicle Screw Cannulated Ti Ø8.5x70mm | In distribution |
| 7728-7525 | Ø7.5 X 25mm Cann Mono Ped Screw | In distribution |
| 7729-8550 | SCREW ASSY CANN OSTEO TI Ø8.5X50MM | In distribution |
| 7729-7560 | Screw Assy Cann Osteo Ti Ø7.5x60mm | In distribution |
| 7723-8535 | Screw Cann Mono Osteo Ti Ø8.5x35mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.