MICRO-SEAL ACETABULAR SYSTEM

MICRO-SEAL ACETABULAR SYSTEM is an FDA 510(k)-cleared medical device (K971718) manufactured by Whiteside Biomechanics, 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 22, 1997. Regulation: 8.