PolyLock Ankle Plates AK-PF-1508
PolyLock Ankle Plates AK-PF-1508 is a Class II device made by Fusion Orthopedics, LLC, cleared under FDA 510(k) K202959 on 24 Nov 2020 and listed in FDA GUDID since 17 Jan 2022 (UDI-DI 00840124505339), active as of 23 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 | Number00840124505339 | Date17 Jan 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202959 | Date24 Nov 2020 | StatusActive |
Official records
- AccessGUDID record 00840124505339
- FDA 510(k) database K202959
Across registries
- FDA 510(k) K202959 decided 24 Nov 2020 Active
- FDA GUDID UDI-DI 00840124505339 listed 17 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K202959
- Listed FDA GUDID 00840124505339
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PolyLock Ankle Plates
- Generic name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Model / Ref / Catalog
- AK-PF-1508
- Primary DI / UDI-DI
- 00840124505339
- 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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