Alignment Gauge handle Long 83104
Alignment Gauge handle Long 83104 is a Class III device made by Premia Spine Ltd, approved under FDA PMA P220002 on 15 Jun 2023 and listed in FDA GUDID since 3 Sep 2024 (UDI-DI 07290115932836), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
PMA
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290115932836 | Date3 Sep 2024 | StatusListed |
| United States | FDA PMAAPPR | NumberP220002 | Date15 Jun 2023 | StatusActive |
Official records
- AccessGUDID record 07290115932836
- FDA PMA database P220002
Across registries
- FDA PMA P220002 decided 15 Jun 2023 Active
- FDA GUDID UDI-DI 07290115932836 listed 3 Sep 2024 Listed
Recalls
-
- Ongoing Z-2516-2025
Potential for missing pins at tip of inserter.
Timeline
- Approved FDA PMA P220002
- Listed FDA GUDID 07290115932836
- Recall initiated FDA recalls Z-2516-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Alignment Gauge handle Long
- Generic name
- Orthopaedic fixation implant alignment tool
- Model / reference
- 83104
- Primary DI / UDI-DI
- 07290115932836
- PMA number
- FDA product code
- QWK
- GMDN term
- Orthopaedic fixation implant alignment tool
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic fixation implant alignment tool.