BENCOX THR System HA.0C5.0028
BENCOX THR System HA.0C5.0028 is a Class II device made by Corentec Co., Ltd, cleared under FDA 510(k) K211866 on 14 Jul 2021 and listed in FDA GUDID since 20 Jul 2021 (UDI-DI 08800068958549), 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 | Number08800068958549 | Date20 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211866 | Date14 Jul 2021 | StatusActive |
Official records
- AccessGUDID record 08800068958549
- FDA 510(k) database K211866
Across registries
- FDA 510(k) K211866 decided 14 Jul 2021 Active
- FDA GUDID UDI-DI 08800068958549 listed 20 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K211866
- Listed FDA GUDID 08800068958549
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BENCOX THR System
- Generic name
- Surgical implant/trial-implant/sizer holder, reusable
- Model / reference
- HA.0C5.0028
- Primary DI / UDI-DI
- 08800068958549
- 510(k) Number
- FDA product code
- LPH, LZO, KWY
- GMDN term
- Surgical implant/trial-implant/sizer holder, reusable
- Device class
- Class II
- Regulation number
- 888.3358, 888.3353, 888.3390
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Surgical implant/trial-implant/sizer holder, reusable.