Lospa Modular Knee System KB.STT.EE26
Lospa Modular Knee System KB.STT.EE26 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 24 Feb 2025 (UDI-DI 08800068975652), 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 | Number08800068975652 | Date24 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222278 | Date26 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 08800068975652
- FDA 510(k) database K222278
Across registries
- FDA 510(k) K222278 decided 26 Aug 2022 Active
- FDA GUDID UDI-DI 08800068975652 listed 24 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K222278
- Listed FDA GUDID 08800068975652
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lospa Modular Knee System
- Generic name
- Knee tibia prosthesis trial, reusable
- Model / reference
- KB.STT.EE26
- Primary DI / UDI-DI
- 08800068975652
- 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
Similar devices in this category
Other devices filed under Knee tibia prosthesis trial, reusable.
- Unity Total Knee System 1236030 by CORIN LTD
- NexGen® Legacy® 5995-30-20 00-5995-030-20 by Zimmer, Inc.
- NexGen® Legacy® 5995-51-23 00-5995-051-23 by Zimmer, Inc.
- OMNIBotics NS-5016R by OMNIlife science, Inc.
- APEX Knee System KS-94611 by OMNIlife science, Inc.
- U2 Total Knee System 2303-2402-RF by UNITED ORTHOPEDIC CORP.
- Unity Total Knee System 123.369.69 by CORIN LTD