EXULT Knee Replacement System KA.CFC.0033
EXULT Knee Replacement System KA.CFC.0033 is a Class II device made by Corentec Co., Ltd, cleared under FDA 510(k) K222278 on 26 Aug 2022 and listed in FDA GUDID since 21 Oct 2022 (UDI-DI 08800068963468), 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 | Number08800068963468 | Date21 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222278 | Date26 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 08800068963468
- FDA 510(k) database K222278
Across registries
- FDA 510(k) K222278 decided 26 Aug 2022 Active
- FDA GUDID UDI-DI 08800068963468 listed 21 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K222278
- Listed FDA GUDID 08800068963468
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EXULT Knee Replacement System
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / reference
- KA.CFC.0033
- Primary DI / UDI-DI
- 08800068963468
- 510(k) Number
- FDA product code
- JWH
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization