Clearance Summary
OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant received FDA 510(k) clearance under submission number K190652, sponsored by OSSIO , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-03-06.
- Submission: K190652
- Applicant / Sponsor: OSSIO , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2020-03-06
Classification & Regulation
This clearance is catalogued under FDA product code HTY and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.