PFIZER/AS&E 0450 LOCALIZER

PFIZER/AS&E 0450 LOCALIZER is an FDA 510(k)-cleared medical device (K800501) manufactured by Pfizer Medical Systems, 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 April 9, 1980. Regulation: 8.