Texas Sidewinder
20 catalogue numbers from T3011, listed by Eminent Spine, United States, under Spinal Vertebral Body Replacement Device. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Eminent Spine, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K090064 |
| Record published | 2017-02-09 |
| Record revised | 2020-02-24 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T3011 | In distribution | |
| T3010 | In distribution | |
| T3014 | In distribution | |
| T4007 | In distribution | |
| T4011 | In distribution | |
| T3016 | In distribution | |
| T3015 | In distribution | |
| T4014 | In distribution | |
| T4015 | In distribution | |
| T3012 | In distribution | |
| T3007 | In distribution | |
| T4008 | In distribution | |
| T4012 | In distribution | |
| T4010 | In distribution | |
| T3009 | In distribution | |
| T4016 | In distribution | |
| T3008 | In distribution | |
| T3013 | In distribution | |
| T4013 | In distribution | |
| T4009 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Spinal Solutions, LLC | 510(k) number | 2013-02-20 | Class II | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. | 24 units | 2014-03-26 |
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.