ActivaNail™ B-ANCO-1525
by Bioretec Oy
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
ActivaNail Conical Orthopedic Bone Pin for fixation of bone fractures or grafts, or osteotomies or arthrodeses in the presence of additional immobilization. Chemically degraded and typically absorbed by natural body processes.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberE302BANCO15259 | 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 E302BANCO15259 listed 25 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K080879
- Listed FDA GUDID E302BANCO15259
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- Withdrawn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-1525
- Primary DI / UDI-DI
- E302BANCO15259
- 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 — 25 Millimeter
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