510(k) K142655
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2015
- Date Received
- September 18, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Spondylolisthesis Spinal Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type