Tornier HRS ARS980927
Tornier HRS ARS980927 is a Class II device made by Tornier, Inc., cleared under FDA 510(k) K241878 on 6 Dec 2024 and listed in FDA GUDID since 16 Dec 2024 (UDI-DI 00846832093694), 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 | Number00846832093694 | Date16 Dec 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241878 | Date6 Dec 2024 | StatusActive |
Official records
- AccessGUDID record 00846832093694
- FDA 510(k) database K241878
Across registries
- FDA 510(k) K241878 decided 6 Dec 2024 Active
- FDA GUDID UDI-DI 00846832093694 listed 16 Dec 2024 Listed
Timeline
- Cleared FDA 510(k) K241878
- Listed FDA GUDID 00846832093694
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tornier HRS
- Generic name
- Coated shoulder humeral stem prosthesis
- Model / Ref / Catalog
- ARS980927
- Primary DI / UDI-DI
- 00846832093694
- 510(k) Number
- FDA product code
- HSD, PHX, KWS
- GMDN term
- Coated shoulder humeral stem prosthesis
- Device class
- Class II
- Regulation number
- 888.3690, 888.3660
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 14 MillimeterLength — 90 Millimeter