510(k) K192117
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2019
- Date Received
- August 6, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Vertebral Body Replacement Device
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type