Endoskeleton VBR
Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 20mm
3manufacturers in China registered for this device type
18catalogue numbers in this listing
1recall
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 | Titan Spine, LLC, 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 | 2015-09-17 |
| Record revised | 2025-07-14 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 18 to 20 mm; depth 21 to 27 mm; width 32 to 40 mm; angle 7 ° |
| Distribution end date | 2020-09-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2107-0320-N | Height 20 mm | Withdrawn |
| 2107-0318 | Height 18 mm | Withdrawn |
| 2107-0120 | Height 20 mm | Withdrawn |
| 2107-0320 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0318-N | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0218-S | Height 18 mm | Withdrawn |
| 2107-0120-N | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0220-N | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0218-N | Height 18 mm | Withdrawn |
| 2107-0118-S | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0318-S | Height 18 mm | Withdrawn |
| 2107-0220-S | Height 20 mm | Withdrawn |
| 2107-0118 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0218 | Height 18 mm | Withdrawn |
| 2107-0220 | Height 20 mm | Withdrawn |
| 2107-0120-S | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0320-S | Height 20 mm | Withdrawn |
| 2107-0118-N | Height 18 mm | Withdrawn |
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 |
|---|---|---|---|---|---|---|---|
| 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.