Head Releaser 80646
Head Releaser 80646 is a Class II device made by Premia Spine Ltd, cleared under FDA 510(k) K231844 on 7 Jul 2023 (2 earlier submissions), approved under FDA PMA P220002 on 15 Jun 2023 and listed in FDA GUDID since 3 Sep 2024 (UDI-DI 07290115932539), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
PMA 510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290115932539 | Date3 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231844 | Date7 Jul 2023 | StatusActive |
| United States | FDA PMAAPPR | NumberP220002 | Date15 Jun 2023 | StatusActive |
Official records
- AccessGUDID record 07290115932539
- FDA 510(k) database K231844
- FDA PMA database P220002
- FDA 510(k) database K170061
- FDA 510(k) database K150380
Across registries
- FDA 510(k) K231844 decided 7 Jul 2023 Active
- FDA PMA P220002 decided 15 Jun 2023 Active
- FDA GUDID UDI-DI 07290115932539 listed 3 Sep 2024 Listed
Recalls
-
- Ongoing Z-2516-2025
Potential for missing pins at tip of inserter.
Timeline
- Cleared FDA 510(k) K150380
- Cleared FDA 510(k) K170061
- Approved FDA PMA P220002
- Cleared FDA 510(k) K231844
- Listed FDA GUDID 07290115932539
- Recall initiated FDA recalls Z-2516-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k), FDA PMA Active
Specification
- Trade name
- Head Releaser
- Generic name
- Orthopaedic instrument extractor
- Model / reference
- 80646
- Primary DI / UDI-DI
- 07290115932539
- PMA number
- FDA product code
- NKB, MNI, MNH, QWK
- GMDN term
- Orthopaedic instrument extractor
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization