Humeris 135 322-0903
by Fx Solutions
Humeris 135 322-0903 is a Class II device made by Fx Solutions, cleared under FDA 510(k) K222936 on 7 Nov 2022 and listed in FDA GUDID since 11 Jan 2023 (UDI-DI 03701037318553), 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 | Number03701037318553 | Date11 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222936 | Date7 Nov 2022 | StatusActive |
Official records
- AccessGUDID record 03701037318553
- FDA 510(k) database K222936
Across registries
- FDA 510(k) K222936 decided 7 Nov 2022 Active
- FDA GUDID UDI-DI 03701037318553 listed 11 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K222936
- Listed FDA GUDID 03701037318553
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Humeris 135
- Generic name
- Polyethylene reverse shoulder prosthesis cup
- Model / Ref / Catalog
- 322-0903
- Primary DI / UDI-DI
- 03701037318553
- 510(k) Number
- FDA product code
- PHX, KWT, HSD
- GMDN term
- Polyethylene reverse shoulder prosthesis cup
- Device class
- Class II
- Regulation number
- 888.3660, 888.3650, 888.3690
- GUDID distribution status
- In Commercial Distribution
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