510(k) K202528
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2020
- Date Received
- September 1, 2020
- Clearance Type
- Traditional
- 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.