
Implex Corp.
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THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ is an FDA 510(k)-cleared medical device (K001471) manufactured by Implex Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 2000. Regulation: 8.