Micro Orca™ AB-7200
Micro Orca™ AB-7200 is a Class II device made by Dunamis Medical LLC, cleared under FDA 510(k) K191319 on 29 Aug 2019 and listed in FDA GUDID since 16 Aug 2023 (UDI-DI 00854629006994), 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 | Number00854629006994 | Date16 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191319 | Date29 Aug 2019 | StatusActive |
Official records
- AccessGUDID record 00854629006994
- FDA 510(k) database K191319
Across registries
- FDA 510(k) K191319 decided 29 Aug 2019 Active
- FDA GUDID UDI-DI 00854629006994 listed 16 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K191319
- Listed FDA GUDID 00854629006994
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Micro Orca™
- Generic name
- Orthopaedic fixation suture button
- Model / Ref / Catalog
- AB-7200
- Primary DI / UDI-DI
- 00854629006994
- 510(k) Number
- FDA product code
- HTN, MBI
- GMDN term
- Orthopaedic fixation suture button
- Device class
- Class II
- Regulation number
- 888.3030, 888.3040
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthopaedic fixation suture button.