510(k) K240935
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2024
- Date Received
- April 5, 2024
- 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