510(k) K193543
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System by
In2bones USA, LLC
— Product Code HRS
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2020
- Date Received
- December 20, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type