Lospa Tkr System KA.SPS.0612
Lospa Tkr System KA.SPS.0612 is a Class I device made by Corentec Co., Ltd, cleared under FDA 510(k) K212034 on 9 Dec 2021 and listed in FDA GUDID since 31 Dec 2021 (UDI-DI 08800068955012), 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 | Number08800068955012 | Date31 Dec 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212034 | Date9 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 08800068955012
- FDA 510(k) database K212034
Across registries
- FDA 510(k) K212034 decided 9 Dec 2021 Active
- FDA GUDID UDI-DI 08800068955012 listed 31 Dec 2021 Listed
Timeline
- Cleared FDA 510(k) K212034
- Listed FDA GUDID 08800068955012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lospa Tkr System
- Generic name
- Knee tibia prosthesis trial, reusable
- Model / reference
- KA.SPS.0612
- Primary DI / UDI-DI
- 08800068955012
- 510(k) Number
- FDA product code
- HWT, JWH
- GMDN term
- Knee tibia prosthesis trial, reusable
- Device class
- Class I
- Regulation number
- 888.4800, 888.3560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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