REDAPT Porous Acetabular Shell

REDAPT Porous Acetabular Shell is an FDA 510(k)-cleared medical device (K181366) manufactured by Smith & Nephew, 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 September 23, 2018. Regulation: 8.