Clearance Summary
OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION received FDA 510(k) clearance under submission number K961725, sponsored by C.L. Mcintosh & Assoc., 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 1996-08-01.
- Submission: K961725
- Applicant / Sponsor: C.L. Mcintosh & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4580
- Decision date: 1996-08-01
Classification & Regulation
This clearance is catalogued under FDA product code JDX and 21 CFR 888.4580, within the Orthopedic review panel as a Class II device.