Counter Torque PER 88875
Counter Torque PER 88875 is a Class II device made by Premia Spine Ltd, cleared under FDA 510(k) K232719 on 21 Nov 2023 and listed in FDA GUDID since 12 Aug 2026 (UDI-DI 07290115935790), active as of 22 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 | Number07290115935790 | Date12 Aug 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232719 | Date21 Nov 2023 | StatusActive |
Official records
- AccessGUDID record 07290115935790
- FDA 510(k) database K232719
Across registries
- FDA 510(k) K232719 decided 21 Nov 2023 Active
- FDA GUDID UDI-DI 07290115935790 listed 12 Aug 2026 Listed
Timeline
- Cleared FDA 510(k) K232719
- Listed FDA GUDID 07290115935790
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Counter Torque PER
- Generic name
- Orthopaedic implant aiming/guiding block attachment tool
- Model / reference
- 88875
- Primary DI / UDI-DI
- 07290115935790
- 510(k) Number
- FDA product code
- NKB
- GMDN term
- Orthopaedic implant aiming/guiding block attachment tool
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization