Clearance Summary
ODALYS PEDICLE SCREW SYSTEM received FDA 510(k) clearance under submission number K111370, sponsored by Kalitec Direct, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-09-21.
- Submission: K111370
- Applicant / Sponsor: Kalitec Direct, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2011-09-21
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.