Prima 1367.09.503
Prima 1367.09.503 is a Class II device made by Limacorporate, cleared under FDA 510(k) K252352 on 22 Jan 2026 and listed in FDA GUDID since 19 Feb 2026 (UDI-DI 08033390202640), 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 | Number08033390202640 | Date19 Feb 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK252352 | Date22 Jan 2026 | StatusActive |
Official records
- AccessGUDID record 08033390202640
- FDA 510(k) database K252352
Across registries
- FDA 510(k) K252352 decided 22 Jan 2026 Active
- FDA GUDID UDI-DI 08033390202640 listed 19 Feb 2026 Listed
Timeline
- Cleared FDA 510(k) K252352
- Listed FDA GUDID 08033390202640
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Prima
- Generic name
- Metallic reverse shoulder prosthesis cup
- Model / Ref / Catalog
- 1367.09.503
- Primary DI / UDI-DI
- 08033390202640
- 510(k) Number
- FDA product code
- PHX, MBF
- GMDN term
- Metallic reverse shoulder prosthesis cup
- Device class
- Class II
- Regulation number
- 888.3660, 888.3670
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PHX (Shoulder Prosthesis, Reverse Configuration).
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- DELTA SHOULDER by Depuy, Inc.
- Shoulder System 04.01.0162 by Medacta International SA
- Comprehensive® Instrumentation 405906 by Biomet Orthopedics, Inc.
- Arthrex Univers Revers Modular Glenoid System by Arthrex, Inc.
- EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW by Exactech, Inc.