510(k) K220724
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2022
- Date Received
- March 14, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thoracolumbosacral Pedicle Screw System
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.