
Instratek, Inc.
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MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 is an FDA 510(k)-cleared medical device (K091763) manufactured by Instratek, 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 August 13, 2009. Regulation: 8.