Catalystem 71314023
Catalystem 71314023 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K240381 on 27 Jun 2024 and listed in FDA GUDID since 23 Aug 2024 (UDI-DI 00885556891599), 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 | Number00885556891599 | Date23 Aug 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240381 | Date27 Jun 2024 | StatusActive |
Official records
- AccessGUDID record 00885556891599
- FDA 510(k) database K240381
Across registries
- FDA 510(k) K240381 decided 27 Jun 2024 Active
- FDA GUDID UDI-DI 00885556891599 listed 23 Aug 2024 Listed
Timeline
- Cleared FDA 510(k) K240381
- Listed FDA GUDID 00885556891599
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Catalystem
- Generic name
- Coated hip femur prosthesis, modular
- Model / Ref / Catalog
- 71314023
- Primary DI / UDI-DI
- 00885556891599
- FDA product code
- LPH, LZO, MEH
- GMDN term
- Coated hip femur prosthesis, modular
- Device class
- Class II
- Regulation number
- 888.3358, 888.3353
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Coated hip femur prosthesis, modular.