Actifuse Flow 506005078077
by Apatech Ltd
Actifuse Flow 506005078077 is a Class II device made by Apatech Ltd, cleared under FDA 510(k) K181306 on 17 Aug 2018 and listed in FDA GUDID since 10 Oct 2018 (UDI-DI 05060050780777), 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 | Number05060050780777 | Date10 Oct 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181306 | Date17 Aug 2018 | StatusActive |
Official records
- AccessGUDID record 05060050780777
- FDA 510(k) database K181306
Across registries
- FDA 510(k) K181306 decided 17 Aug 2018 Active
- FDA GUDID UDI-DI 05060050780777 listed 10 Oct 2018 Listed
Timeline
- Cleared FDA 510(k) K181306
- Listed FDA GUDID 05060050780777
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Actifuse Flow
- Generic name
- Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
- Model / Ref / Catalog
- 506005078077
- Primary DI / UDI-DI
- 05060050780777
- 510(k) Number
- FDA product code
- MQV
- GMDN term
- Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
- Device class
- Class II
- Regulation number
- 888.3045
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 3 Milliliter
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