510(k) K122081
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2013
- Date Received
- July 16, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type