EXULT Knee Replacement System KA.IUC.RB09
EXULT Knee Replacement System KA.IUC.RB09 is a Class II device made by Corentec Co., Ltd, cleared under FDA 510(k) K250889 on 17 Apr 2025 and listed in FDA GUDID since 28 Apr 2025 (UDI-DI 08809945894765), 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 | Number08809945894765 | Date28 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250889 | Date17 Apr 2025 | StatusActive |
Official records
- AccessGUDID record 08809945894765
- FDA 510(k) database K250889
Across registries
- FDA 510(k) K250889 decided 17 Apr 2025 Active
- FDA GUDID UDI-DI 08809945894765 listed 28 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K250889
- Listed FDA GUDID 08809945894765
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EXULT Knee Replacement System
- Generic name
- Knee tibia prosthesis trial, reusable
- Model / reference
- KA.IUC.RB09
- Primary DI / UDI-DI
- 08809945894765
- 510(k) Number
- FDA product code
- JWH
- GMDN term
- Knee tibia prosthesis trial, reusable
- Device class
- Class II
- Regulation number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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