BIO2 Technologies 100-0129
BIO2 Technologies 100-0129 is a Class II device made by BIO2 Technologies, Inc., cleared under FDA 510(k) K151876 on 30 Dec 2015 and listed in FDA GUDID since 12 May 2017 (UDI-DI B01010001291), 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 | NumberB01010001291 | Date12 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151876 | Date30 Dec 2015 | StatusActive |
Official records
- FDA 510(k) database K151876
Across registries
- FDA 510(k) K151876 decided 30 Dec 2015 Active
- FDA GUDID UDI-DI B01010001291 listed 12 May 2017 Listed
Timeline
- Cleared FDA 510(k) K151876
- Listed FDA GUDID B01010001291
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BIO2 Technologies
- Generic name
- Orthopaedic bone pin, bioabsorbable
- Model / reference
- 100-0129
- Primary DI / UDI-DI
- B01010001291
- 510(k) Number
- FDA product code
- HTY
- GMDN term
- Orthopaedic bone pin, bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
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