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Implex Corp.
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THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) is an FDA 510(k)-cleared medical device (K012507) 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 29, 2001. Regulation: 8.