Veritas Reverse Total Shoulder 6500-9002
by Restor3D
Veritas Reverse Total Shoulder 6500-9002 is a Class II device made by Restor3D, cleared under FDA 510(k) K253992 on 7 May 2026 and listed in FDA GUDID since 24 Jul 2026 (UDI-DI 00840097513126), active as of 23 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 | Number00840097513126 | Date24 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK253992 | Date7 May 2026 | StatusActive |
Official records
- AccessGUDID record 00840097513126
- FDA 510(k) database K253992
Across registries
- FDA 510(k) K253992 decided 7 May 2026 Active
- FDA GUDID UDI-DI 00840097513126 listed 24 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K253992
- Listed FDA GUDID 00840097513126
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Veritas Reverse Total Shoulder
- Generic name
- Shoulder reverse/standard adaptor prosthesis trial
- Model / reference
- 6500-9002
- Primary DI / UDI-DI
- 00840097513126
- 510(k) Number
- FDA product code
- PHX, QHE
- GMDN term
- Shoulder reverse/standard adaptor prosthesis trial
- Device class
- Class II
- Regulation number
- 888.3660
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization