S-Rom Noiles 62-1635
S-Rom Noiles 62-1635 (621635) is a Class II device made by Depuy (Ireland), cleared under FDA 510(k) K241000 on 11 Jul 2024 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295179085), 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 | FDA 510(k) | NumberK241000 | Date11 Jul 2024 | StatusActive |
| United States | GUDID listing | Number10603295179085 | Date24 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 10603295179085
- FDA 510(k) database K241000
- FDA 510(k) database K936037
Across registries
- FDA 510(k) K241000 decided 11 Jul 2024 Active
- FDA GUDID UDI-DI 10603295179085 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K936037
- Listed FDA GUDID 10603295179085
- Cleared FDA 510(k) K241000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- S-Rom Noiles
- Generic name
- Polyethylene patella prosthesis
- Model / Ref / Catalog
- 62-1635, 621635
- Primary DI / UDI-DI
- 10603295179085
- FDA product code
- JWH
- GMDN term
- Polyethylene patella prosthesis
- Device class
- Class II
- Regulation number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional