OGDEN ANCHOR-SMALL (TENTATIVE)

OGDEN ANCHOR-SMALL (TENTATIVE) is an FDA 510(k)-cleared medical device (K941029) manufactured by American Medical Electronics, 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 February 8, 1995. Regulation: 8.