
Tgm Medical, Inc.
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ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT is an FDA 510(k)-cleared medical device (K121636) manufactured by Tgm Medical, 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 October 23, 2012. Regulation: 8.