Clearance Summary
OSTEONICS SR GLENOID COMPONENTS received FDA 510(k) clearance under submission number K903886, sponsored by Osteonics Reconstructive Products Div.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-11-20.
- Submission: K903886
- Applicant / Sponsor: Osteonics Reconstructive Products Div.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 1990-11-20
Classification & Regulation
This clearance is catalogued under FDA product code KWS and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.