Fix2Lock BHA-4820-3210
Fix2Lock BHA-4820-3210 is a Class II device made by OSTEONIC CO., Ltd., cleared under FDA 510(k) K202806 on 17 Jun 2021 and listed in FDA GUDID since 5 Jul 2021 (UDI-DI 08809595976460), 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 | Number08809595976460 | Date5 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202806 | Date17 Jun 2021 | StatusActive |
Official records
- AccessGUDID record 08809595976460
- FDA 510(k) database K202806
Across registries
- FDA 510(k) K202806 decided 17 Jun 2021 Active
- FDA GUDID UDI-DI 08809595976460 listed 5 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K202806
- Listed FDA GUDID 08809595976460
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fix2Lock
- Generic name
- Tendon/ligament bone anchor, bioabsorbable
- Model / reference
- BHA-4820-3210
- Primary DI / UDI-DI
- 08809595976460
- 510(k) Number
- FDA product code
- MAI, MBI
- GMDN term
- Tendon/ligament bone anchor, bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3030, 888.3040
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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