
Aesculap Implant Systems, Inc.
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MODIFICATION TO: METHA HIP SYSTEM is an FDA 510(k)-cleared medical device (K083495) manufactured by Aesculap Implant Systems, 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 January 14, 2009. Regulation: 8.