Orca™ Mini Knotless Button AB-6300
Orca™ Mini Knotless Button AB-6300 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 31 Jan 2024 (UDI-DI 20854629006912), 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 | Number20854629006912 | Date31 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191319 | Date29 Aug 2019 | StatusActive |
Official records
- AccessGUDID record 20854629006912
- FDA 510(k) database K191319
Across registries
- FDA 510(k) K191319 decided 29 Aug 2019 Active
- FDA GUDID UDI-DI 20854629006912 listed 31 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K191319
- Listed FDA GUDID 20854629006912
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Orca™ Mini Knotless Button
- Generic name
- Orthopaedic fixation suture button
- Model / Ref / Catalog
- AB-6300
- Primary DI / UDI-DI
- 20854629006912
- 510(k) Number
- FDA product code
- MBI, HTN
- GMDN term
- Orthopaedic fixation suture button
- Device class
- Class II
- Regulation number
- 888.3040, 888.3030
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthopaedic fixation suture button.