510(k) K181562
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2018
- Date Received
- June 14, 2018
- Clearance Type
- Traditional
- 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