LOSPA Modular Knee System KB.SFT.0505B
LOSPA Modular Knee System KB.SFT.0505B 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 23 Oct 2022 (UDI-DI 08800068965080), 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 | Number08800068965080 | Date23 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222278 | Date26 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 08800068965080
- FDA 510(k) database K222278
Across registries
- FDA 510(k) K222278 decided 26 Aug 2022 Active
- FDA GUDID UDI-DI 08800068965080 listed 23 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K222278
- Listed FDA GUDID 08800068965080
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LOSPA Modular Knee System
- Generic name
- Knee femur prosthesis trial, reusable
- Model / reference
- KB.SFT.0505B
- Primary DI / UDI-DI
- 08800068965080
- 510(k) Number
- FDA product code
- JWH
- GMDN term
- Knee femur 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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