Htr-Pmi PM619292
Htr-Pmi PM619292 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K924935 on 2 Sep 1993 and listed in FDA GUDID since 6 Apr 2017 (UDI-DI 00841036229689), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00841036229689 | Date6 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK924935 | Date2 Sep 1993 | StatusActive |
Official records
- AccessGUDID record 00841036229689
- FDA 510(k) database K924935
Across registries
- FDA 510(k) K924935 decided 2 Sep 1993 Active
- FDA GUDID UDI-DI 00841036229689 listed 6 Apr 2017 Listed
Recalls
-
- Terminated Z-2751-2016
Potential sterility deficiency.
Timeline
- Cleared FDA 510(k) K924935
- Recall initiated FDA recalls Z-2751-2016
- Listed FDA GUDID 00841036229689
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Htr-Pmi
- Generic name
- Cranioplasty plate, non-alterable
- Model / reference
- PM619292
- Primary DI / UDI-DI
- 00841036229689
- 510(k) Number
- FDA product code
- LZK, KKY, FZE, FWP
- GMDN term
- Cranioplasty plate, non-alterable
- Device class
- Class II
- Regulation number
- 878.3550, 878.3500, 878.3680
- GUDID distribution status
- In Commercial Distribution