510(k) K150229
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2015
- Date Received
- February 2, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Interlaminal
- Device Class
- Class II
- Regulation Number
- 888.3050
- Review Panel
- OR
- Submission Type