PolyLock ML-LK-2410
PolyLock ML-LK-2410 is a Class II device made by Fusion Orthopedics, LLC, cleared under FDA 510(k) K211843 on 4 Mar 2022 and listed in FDA GUDID since 20 May 2024 (UDI-DI 00840124509900), 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 | Number00840124509900 | Date20 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211843 | Date4 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 00840124509900
- FDA 510(k) database K211843
Across registries
- FDA 510(k) K211843 decided 4 Mar 2022 Active
- FDA GUDID UDI-DI 00840124509900 listed 20 May 2024 Listed
Timeline
- Cleared FDA 510(k) K211843
- Listed FDA GUDID 00840124509900
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PolyLock
- Generic name
- Implantable orthopaedic/craniofacial device connection screw
- Model / reference
- ML-LK-2410
- Primary DI / UDI-DI
- 00840124509900
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Implantable orthopaedic/craniofacial device connection screw
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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