Omni Stable AF 144-12023
Omni Stable AF 144-12023 is a Class II device made by Extremity Medical, LLC, cleared under FDA 510(k) K212297 on 20 Aug 2021 and listed in FDA GUDID since 12 Jun 2023 (UDI-DI 00842078120453), 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 | Number00842078120453 | Date12 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212297 | Date20 Aug 2021 | StatusActive |
Official records
- AccessGUDID record 00842078120453
- FDA 510(k) database K212297
Across registries
- FDA 510(k) K212297 decided 20 Aug 2021 Active
- FDA GUDID UDI-DI 00842078120453 listed 12 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K212297
- Listed FDA GUDID 00842078120453
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Omni Stable AF
- Generic name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Model / reference
- 144-12023
- Primary DI / UDI-DI
- 00842078120453
- 510(k) Number
- FDA product code
- HRS
- GMDN term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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