Veritas rTSA 1500-1035
by Restor3D
Veritas rTSA 1500-1035 is a Class II device made by Restor3D, cleared under FDA 510(k) K243643 on 19 May 2025 and listed in FDA GUDID since 14 May 2026 (UDI-DI 00840097513232), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840097513232 | Date14 May 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243643 | Date19 May 2025 | StatusActive |
Official records
- AccessGUDID record 00840097513232
- FDA 510(k) database K243643
Across registries
- FDA 510(k) K243643 decided 19 May 2025 Active
- FDA GUDID UDI-DI 00840097513232 listed 14 May 2026 Listed
Recalls
-
- Ongoing Z-2987-2026
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
Timeline
- Cleared FDA 510(k) K243643
- Listed FDA GUDID 00840097513232
- Recall initiated FDA recalls Z-2987-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Veritas rTSA
- Generic name
- Total reverse shoulder prosthesis
- Model / reference
- 1500-1035
- Primary DI / UDI-DI
- 00840097513232
- 510(k) Number
- FDA product code
- PHX
- GMDN term
- Total reverse shoulder prosthesis
- Device class
- Class II
- Regulation number
- 888.3660
- GUDID distribution status
- In Commercial Distribution