OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION

OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION is an FDA 510(k)-cleared medical device (K961725) manufactured by C.L. Mcintosh & Assoc., Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 1996. Regulation: 8.