Clearance Summary
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES received FDA 510(k) clearance under submission number K132733, sponsored by Orthohelix Surgical Designs, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-01-03.
- Submission: K132733
- Applicant / Sponsor: Orthohelix Surgical Designs, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2014-01-03
Classification & Regulation
This clearance is catalogued under FDA product code HTN and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.