ActivaScrew™ B-ASC-3536
by Bioretec Oy
ActivaScrew™ B-ASC-3536 is a Class II device made by Bioretec Oy, cleared under FDA 510(k) K081392 on 18 Jun 2008 and listed in FDA GUDID since 26 Aug 2015 (UDI-DI E302BASC35369), 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 | NumberE302BASC35369 | Date26 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081392 | Date18 Jun 2008 | StatusActive |
Official records
- FDA 510(k) database K081392
Across registries
- FDA 510(k) K081392 decided 18 Jun 2008 Active
- FDA GUDID UDI-DI E302BASC35369 listed 26 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K081392
- Listed FDA GUDID E302BASC35369
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ActivaScrew™
- Generic name
- Bioabsorbable orthopaedic bone screw
- Model / Ref / Catalog
- B-ASC-3536
- Primary DI / UDI-DI
- E302BASC35369
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Bioabsorbable orthopaedic bone screw
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Size
- Width — 3.5 MillimeterLength — 36 Millimeter
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