510(k) K262091
K262091 is an FDA 510(k) premarket notification submitted by Ortler Global Tibbi Gerecler Anonim Sirketi for the device "FRAXION Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on September 17, 2026. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Ortler Global Tibbi Gerecler Anonim Sirketi has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2026
- Date Received
- June 22, 2026
- 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.