
Centerpulse Orthopedics, Inc.
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EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED is an FDA 510(k)-cleared medical device (K033634) manufactured by Centerpulse Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 14, 2004. Regulation: 8.