Clearance Summary
OSSIOfiber® Staple received FDA 510(k) clearance under submission number K212594, 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 2022-01-21.
- Submission: K212594
- Applicant / Sponsor: OSSIO , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2022-01-21
Classification & Regulation
This clearance is catalogued under FDA product code MNU and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.