510(k) K162033
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2017
- Date Received
- July 22, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type