Telluride® MIS Spinal Fixation System
147 catalogue numbers from 7711-1085, 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
147catalogue 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 | 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 |
|---|---|---|
| 7711-1085 | Rod Percutaneous Med Curved Ti ø5.5×85 | In distribution |
| 7723-6520 | SCREW CANN MONO OSTEO TI Ø6.5X20MM | In distribution |
| 7711-0120 | Rod Percutaneous Straight Ti ø5.5×120 | In distribution |
| 7729-6555 | SCREW ASSY CANN OSTEO TI Ø6.5X55MM | In distribution |
| 7729-8550 | Screw Assy Cann Osteo Ti Ø8.5x50mm | In distribution |
| 7723-6540 | Screw Cann Mono Osteo Ti Ø6.5x40mm | In distribution |
| 7723-8525 | SCREW CANN MONO OSTEO TI Ø8.5X25MM | In distribution |
| 7729-7560 | SCREW ASSY CANN OSTEO TI Ø7.5X60MM | In distribution |
| 7723-6555 | SCREW CANN MONO OSTEO TI Ø6.5X55MM | In distribution |
| 7711-0095 | Rod Percutaneous Straight Ti ø5.5×95 | In distribution |
| 7711-0055 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X55 | In distribution |
| 7728-0545 | Ø10.5 X 45MM CANN MONO TI PED SCREW | In distribution |
| 7716-6570 | PEDICLE SCREW CANNULATED TI Ø6.5X70MM | In distribution |
| 7711-1025 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X25 | In distribution |
| 7728-6555 | Ø6.5 X 55mm Cann Mono Ped Screw | In distribution |
| 7716-7550 | PEDICLE SCREW CANNULATED TI Ø7.5X50MM | In distribution |
| 7711-0500 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X500 | In distribution |
| 7716-8565 | Pedicle Screw Cannulated Ti Ø8.5x65mm | In distribution |
| 7728-7540 | Ø7.5 X 40mm Cann Mono Ped Screw | In distribution |
| 7723-6540 | SCREW CANN MONO OSTEO TI Ø6.5X40MM | In distribution |
| 7728-5570 | Ø5.5 X 70mm Cann Mono Ped Screw | In distribution |
| 7723-0525 | Screw Cann Mono Osteo Ti Ø10.5x25mm | In distribution |
| 7723-6530 | Screw Cann Mono Osteo Ti Ø6.5x30mm | In distribution |
| 7723-7545 | Screw Cann Mono Osteo Ti Ø7.5x45mm | In distribution |
| 7728-5545 | Ø5.5 X 45MM CANN MONO PED SCREW | In distribution |
| 7728-7530 | Ø7.5 X 30MM CANN MONO PED SCREW | In distribution |
| 7723-9550 | Screw Cann Mono Osteo Ti Ø9.5x50mm | In distribution |
| 7711-0180 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X180 | In distribution |
| 7716-5545 | PEDICLE SCREW CANNULATED TI Ø5.5X45MM | In distribution |
| 7728-7560 | Ø7.5 X 60MM CANN MONO PED SCREW | In distribution |
| 7711-1085 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X85 | In distribution |
| 7711-1100 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X100 | In distribution |
| 7711-1075 | Rod Percutaneous Med Curved Ti ø5.5×75 | In distribution |
| 7711-0150 | Rod Percutaneous Straight Ti ø5.5×150 | In distribution |
| 7728-8550 | Ø8.5 X 50MM CANN MONO PED SCREW | In distribution |
| 7723-8530 | SCREW CANN MONO OSTEO TI Ø8.5X30MM | In distribution |
| 7711-0085 | Rod Percutaneous Straight Ti ø5.5×85 | In distribution |
| 7711-0060 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X60 | In distribution |
| 7723-8565 | Screw Cann Mono Osteo Ti Ø8.5x65mm | In distribution |
| 7723-7530 | Screw Cann Mono Osteo Ti Ø7.5x30mm | In distribution |
| 7729-6535 | SCREW ASSY CANN OSTEO TI Ø6.5X35MM | In distribution |
| 7728-5545 | Ø5.5 X 45mm Cann Mono Ped Screw | In distribution |
| 7716-5555 | Pedicle Screw Cannulated Ti Ø5.5x55mm | In distribution |
| 7723-9540 | SCREW CANN MONO OSTEO TI Ø9.5X40MM | In distribution |
| 7729-7535 | SCREW ASSY CANN OSTEO TI Ø7.5X35MM | In distribution |
| 7711-0050 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X50 | In distribution |
| 7723-6550 | Screw Cann Mono Osteo Ti Ø6.5x50mm | In distribution |
| 7723-0565 | Screw Cann Mono Osteo Ti Ø10.5x65mm | In distribution |
| 7729-7530 | SCREW ASSY CANN OSTEO TI Ø7.5X30MM | In distribution |
| 7728-5530 | Ø5.5 X 30mm Cann Mono Ped Screw | In distribution |
| 7716-6570 | Pedicle Screw Cannulated Ti Ø6.5x70mm | In distribution |
| 7728-7530 | Ø7.5 X 30mm Cann Mono Ped Screw | In distribution |
| 7723-0540 | SCREW CANN MONO OSTEO TI Ø10.5X40MM | In distribution |
| 7711-0020 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X20 | In distribution |
| 7716-5545 | Pedicle Screw Cannulated Ti Ø5.5x45mm | In distribution |
| 7723-5555 | Screw Cann Mono Osteo Ti Ø5.5x55mm | In distribution |
| 7723-5555 | SCREW CANN MONO OSTEO TI Ø5.5X55MM | In distribution |
| 7711-1020 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X20 | In distribution |
| 7711-1060 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X60 | In distribution |
| 7723-7565 | Screw Cann Mono Osteo Ti Ø7.5x65mm | In distribution |
| 7716-7570 | PEDICLE SCREW CANNULATED TI Ø7.5X70MM | In distribution |
| 7723-5530 | Screw Cann Mono Osteo Ti Ø5.5x30mm | In distribution |
| 7711-0070 | Rod Percutaneous Straight Ti ø5.5×70 | In distribution |
| 7723-8530 | Screw Cann Mono Osteo Ti Ø8.5x30mm | In distribution |
| 7723-9525 | Screw Cann Mono Osteo Ti Ø9.5x25mm | In distribution |
| 7728-7555 | Ø7.5 X 55mm Cann Mono Ped Screw | In distribution |
| 7723-9545 | Screw Cann Mono Osteo Ti Ø9.5x45mm | In distribution |
| 7711-0075 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X75 | In distribution |
| 7711-0130 | Rod Percutaneous Straight Ti ø5.5×130 | In distribution |
| 7711-0110 | Rod Percutaneous Straight Ti ø5.5×110 | In distribution |
| 7716-5530 | PEDICLE SCREW CANNULATED TI Ø5.5X30MM | In distribution |
| 7711-0080 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X80 | In distribution |
| 7729-8535 | SCREW ASSY CANN OSTEO TI Ø8.5X35MM | In distribution |
| 7711-0170 | Rod Percutaneous Straight Ti ø5.5×170 | In distribution |
| 7716-5565 | Pedicle Screw Cannulated Ti Ø5.5x65mm | In distribution |
| 7728-0535 | Ø10.5 x 35mm Cann Mono Ti Ped Screw | In distribution |
| 7729-7540 | SCREW ASSY CANN OSTEO TI Ø7.5X40MM | In distribution |
| 7729-5555 | SCREW ASSY CANN OSTEO TI Ø5.5X55MM | In distribution |
| 7728-0570 | Ø10.5 X 70MM CANN MONO TI PED SCREW | In distribution |
| 7729-7550 | SCREW ASSY CANN OSTEO TI Ø7.5X50MM | In distribution |
| 7728-6555 | Ø6.5 X 55MM CANN MONO PED SCREW | In distribution |
| 7716-6520 | Pedicle Screw Cannulated Ti Ø6.5x20mm | In distribution |
| 7729-5525 | SCREW ASSY CANN OSTEO TI Ø5.5X25MM | In distribution |
| 7711-1070 | Rod Percutaneous Med Curved Ti ø5.5×70 | In distribution |
| 7728-9570 | Ø9.5 X 70mm Cann Mono Ped Screw | In distribution |
| 7711-0075 | Rod Percutaneous Straight Ti ø5.5×75 | In distribution |
| 7728-8545 | Ø8.5 X 45MM CANN MONO PED SCREW | In distribution |
| 7711-1050 | Rod Percutaneous Med Curved Ti ø5.5×50 | In distribution |
| 7716-5555 | PEDICLE SCREW CANNULATED TI Ø5.5X55MM | In distribution |
| 7728-8540 | Ø8.5 X 40mm Cann Mono Ped Screw | In distribution |
| 7716-5520 | PEDICLE SCREW CANNULATED TI Ø5.5X20MM | In distribution |
| 7729-8545 | SCREW ASSY CANN OSTEO TI Ø8.5X45MM | In distribution |
| 7716-5570 | Pedicle Screw Cannulated Ti Ø5.5x70mm | In distribution |
| 7711-0125 | Rod Percutaneous Straight Ti ø5.5×125 | In distribution |
| 7716-8520 | Pedicle Screw Cannulated Ti Ø8.5x20mm | In distribution |
| 7723-7550 | Screw Cann Mono Osteo Ti Ø7.5x50mm | In distribution |
| 7716-6535 | PEDICLE SCREW CANNULATED TI Ø6.5X35MM | In distribution |
| 7716-7520 | Pedicle Screw Cannulated Ti Ø7.5x20mm | In distribution |
| 7711-1080 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X80 | In distribution |
| 7723-6570 | SCREW CANN MONO OSTEO TI Ø6.5X70MM | In distribution |
| 7728-5560 | Ø5.5 X 60MM CANN MONO PED SCREW | In distribution |
| 7723-5560 | Screw Cann Mono Osteo Ti Ø5.5x60mm | In distribution |
| 7723-9570 | SCREW CANN MONO OSTEO TI Ø9.5X70MM | In distribution |
| 7723-0525 | SCREW CANN MONO OSTEO TI Ø10.5X25MM | In distribution |
| 7728-9555 | Ø9.5 X 55mm Cann Mono Ped Screw | In distribution |
| 7716-6560 | PEDICLE SCREW CANNULATED TI Ø6.5X60MM | In distribution |
| 7728-5520 | Ø5.5 X 20MM CANN MONO PED SCREW | In distribution |
| 7723-7560 | SCREW CANN MONO OSTEO TI Ø7.5X60MM | In distribution |
| 7711-0300 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X300 | In distribution |
| 7728-7540 | Ø7.5 X 40MM CANN MONO PED SCREW | In distribution |
| 7716-5550 | PEDICLE SCREW CANNULATED TI Ø5.5X50MM | In distribution |
| 7711-0090 | ROD PERCUTANEOUS STRAIGHT TI Ø5.5X90 | In distribution |
| 7728-8545 | Ø8.5 X 45mm Cann Mono Ped Screw | In distribution |
| 7728-7535 | Ø7.5 X 35mm Cann Mono Ped Screw | In distribution |
| 7716-6540 | Pedicle Screw Cannulated Ti Ø6.5x40mm | In distribution |
| 7729-5535 | SCREW ASSY CANN OSTEO TI Ø5.5X35MM | In distribution |
| 7711-1075 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X75 | In distribution |
| 7723-6525 | Screw Cann Mono Osteo Ti Ø6.5x25mm | In distribution |
| 7716-5560 | PEDICLE SCREW CANNULATED TI Ø5.5X60MM | In distribution |
| 7729-8570 | SCREW ASSY CANN OSTEO TI Ø8.5X70MM | In distribution |
| 7728-9540 | Ø9.5 X 40mm Cann Mono Ped Screw | In distribution |
| 7729-6530 | Screw Assy Cann Osteo Ti Ø6.5x30mm | In distribution |
| 7729-5560 | SCREW ASSY CANN OSTEO TI Ø5.5X60MM | In distribution |
| 7723-7530 | SCREW CANN MONO OSTEO TI Ø7.5X30MM | In distribution |
| 7729-7540 | Screw Assy Cann Osteo Ti Ø7.5x40mm | In distribution |
| 7728-8535 | Ø8.5 X 35mm Cann Mono Ped Screw | In distribution |
| 7723-7565 | SCREW CANN MONO OSTEO TI Ø7.5X65MM | In distribution |
| 7729-8530 | Screw Assy Cann Osteo Ti Ø8.5x30mm | In distribution |
| 7728-6570 | Ø6.5 X 70MM CANN MONO PED SCREW | In distribution |
| 7723-5550 | Screw Cann Mono Osteo Ti Ø5.5x50mm | In distribution |
| 7716-7545 | Pedicle Screw Cannulated Ti Ø7.5x45mm | In distribution |
| 7723-9560 | Screw Cann Mono Osteo Ti Ø9.5x60mm | In distribution |
| 7711-1070 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X70 | In distribution |
| 7728-9535 | Ø9.5 X 35mm Cann Mono Ped Screw | In distribution |
| 7729-7545 | Screw Assy Cann Osteo Ti Ø7.5x45mm | In distribution |
| 7723-0535 | Screw Cann Mono Osteo Ti Ø10.5x35mm | In distribution |
| 7728-7565 | Ø7.5 X 65mm Cann Mono Ped Screw | In distribution |
| 7729-7520 | SCREW ASSY CANN OSTEO TI Ø7.5X20MM | In distribution |
| 7711-1100 | Rod Percutaneous Med Curved Ti ø5.5×100 | In distribution |
| 7728-6525 | Ø6.5 X 25MM CANN MONO PED SCREW | In distribution |
| 7716-8565 | PEDICLE SCREW CANNULATED TI Ø8.5X65MM | In distribution |
| 7728-5530 | Ø5.5 X 30MM CANN MONO PED SCREW | In distribution |
| 7728-9550 | Ø9.5 X 50MM CANN MONO PED SCREW | In distribution |
| 7723-9550 | SCREW CANN MONO OSTEO TI Ø9.5X50MM | In distribution |
| 7711-1030 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X30 | In distribution |
| 7729-8530 | SCREW ASSY CANN OSTEO TI Ø8.5X30MM | In distribution |
| 7711-1035 | ROD PERCUTANEOUS MED CURVED TI Ø5.5X35 | In distribution |
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.