ActivaNail™ B-ANCO-1515
by Bioretec Oy
ActivaNail™ B-ANCO-1515 is a Class II device made by Bioretec Oy, cleared under FDA 510(k) K080879 on 24 Jun 2008 and listed in FDA GUDID since 25 Aug 2015 (UDI-DI E302BANCO15159), active as of 22 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 | NumberE302BANCO15159 | Date25 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080879 | Date24 Jun 2008 | StatusActive |
Official records
- FDA 510(k) database K080879
Across registries
- FDA 510(k) K080879 decided 24 Jun 2008 Active
- FDA GUDID UDI-DI E302BANCO15159 listed 25 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K080879
- Listed FDA GUDID E302BANCO15159
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ActivaNail™
- Generic name
- Orthopaedic bone pin, bioabsorbable
- Model / Ref / Catalog
- B-ANCO-1515
- Primary DI / UDI-DI
- E302BANCO15159
- 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
- MRI safety
- MR Safe
- Size
- Width — 1.5 MillimeterLength — 15 Millimeter
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