PolyLock Midfoot TN-MF-7540
PolyLock Midfoot TN-MF-7540 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 3 Jun 2021 (UDI-DI 00840124504721), 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 | Number00840124504721 | Date3 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202959 | Date24 Nov 2020 | StatusActive |
Official records
- AccessGUDID record 00840124504721
- FDA 510(k) database K202959
Across registries
- FDA 510(k) K202959 decided 24 Nov 2020 Active
- FDA GUDID UDI-DI 00840124504721 listed 3 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K202959
- Listed FDA GUDID 00840124504721
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PolyLock Midfoot
- Generic name
- Surgical drill guide, single-use
- Model / Ref / Catalog
- TN-MF-7540
- Primary DI / UDI-DI
- 00840124504721
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Surgical drill guide, single-use
- 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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