
Biomet, Inc.
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100KGY E-POLY MAXROM ACETABULAR LINERS is an FDA 510(k)-cleared medical device (K070364) manufactured by Biomet, 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 May 2, 2007. Regulation: 8.