Humeris Shoulder 316-0106
by Fx Solutions
Humeris Shoulder 316-0106 is a Class II device made by Fx Solutions, cleared under FDA 510(k) K163669 on 17 May 2017 and listed in FDA GUDID since 22 May 2017 (UDI-DI 03701037303214), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number03701037303214 | Date22 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163669 | Date17 May 2017 | StatusActive |
Official records
- AccessGUDID record 03701037303214
- FDA 510(k) database K163669
Across registries
- FDA 510(k) K163669 decided 17 May 2017 Active
- FDA GUDID UDI-DI 03701037303214 listed 22 May 2017 Listed
Timeline
- Cleared FDA 510(k) K163669
- Listed FDA GUDID 03701037303214
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Humeris Shoulder
- Generic name
- Uncoated shoulder humeral stem prosthesis
- Model / Ref / Catalog
- 316-0106
- Primary DI / UDI-DI
- 03701037303214
- 510(k) Number
- FDA product code
- PHX, KWT
- GMDN term
- Uncoated shoulder humeral stem prosthesis
- Device class
- Class II
- Regulation number
- 888.3660, 888.3650
- GUDID distribution status
- Not in Commercial Distribution
Similar devices in this category
Other devices filed under Uncoated shoulder humeral stem prosthesis.