
Medshape Solutions, Inc.
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EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) is an FDA 510(k)-cleared medical device (K111471) manufactured by Medshape Solutions, 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 June 9, 2011. Regulation: 8.