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Biomet Manufacturing Corp
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BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS is an FDA 510(k)-cleared medical device (K060121) manufactured by Biomet Manufacturing Corp. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 2006. Regulation: 8.