510(k) K132704
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2013
- Date Received
- August 29, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type