Mesh 1007654
Mesh 1007654 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K023319 on 4 Mar 2003 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00887517055415), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00887517055415 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023319 | Date4 Mar 2003 | StatusActive |
Official records
- AccessGUDID record 00887517055415
- FDA 510(k) database K023319
Across registries
- FDA 510(k) K023319 decided 4 Mar 2003 Active
- FDA GUDID UDI-DI 00887517055415 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K023319
- Listed FDA GUDID 00887517055415
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mesh
- Generic name
- Vertebral body prosthesis
- Model / reference
- 1007654
- Primary DI / UDI-DI
- 00887517055415
- 510(k) Number
- FDA product code
- MQP
- GMDN term
- Vertebral body prosthesis
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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- T2 STRATOSPHERE™ Expandable Corpectomy System 436013A by MEDTRONIC SOFAMOR DANEK, INC.
- X-MESH EXPANDABLE CAGE SYSTEM by Depuy Spine, Inc.
- STRYKER SPINE VERTEBRAL SPACER by Stryker Spine