Endoskeleton® TA VBR nanoLOCK® Surface Technology
Interbody Fusion Device 7 Degree Standard 20mm
3manufacturers in China registered for this device type
4catalogue numbers in this listing
30510(k) clearances naming this product code
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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K032812 |
| Record published | 2016-12-15 |
| Record revised | 2025-07-14 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Depth 21 to 24 mm; width 32 to 36 mm; angle 7 °; height 18 to 20 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2107-0218-N | width(MLxAP), 36 x 24, mm | In distribution |
| 2107-0120-N | width(MLxAP), 32 x 21, mm | In distribution |
| 2107-0118-N | width(MLxAP), 32 x 21, mm | In distribution |
| 2107-0220-N | Angle 7 ° | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173125 | 2017-12-20 |
| K131888 | 2013-09-23 |
| K082112 | 2008-08-27 |
| K071033 | 2007-08-14 |
| K070173 | 2007-03-14 |
| K063491 | 2007-03-05 |
| K062427 | 2006-09-12 |
| K062073 | 2006-08-14 |
| K061938 | 2006-08-09 |
| K060719 | 2006-04-14 |
| K052931 | 2005-11-16 |
| K051105 | 2005-06-09 |
| K043566 | 2005-01-07 |
| K043561 | 2004-12-29 |
| K041197 | 2004-08-09 |
| K033926 | 2004-07-07 |
| K041556 | 2004-07-01 |
| K041452 | 2004-06-24 |
| K040536 | 2004-05-05 |
| K040422 | 2004-03-19 |
| K040167 | 2004-02-18 |
| K031780 | 2003-07-30 |
| K030735 | 2003-04-18 |
| K030736 | 2003-04-02 |
| K030601 | 2003-03-25 |
| K024049 | 2003-02-26 |
| K023570 | 2002-11-19 |
| K021791 | 2002-08-26 |
| K011406 | 2001-12-27 |
| K010930 | 2001-10-24 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2021-03-17 | Class II | Packaging process control | The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device. | 11 devices | 2023-05-03 |
| Titan Spine, LLC | 510(k) number | 2012-10-19 | Class II | Labeling False and Misleading | Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use. | 92 pcs. | 2013-01-14 |
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.