
A.M. Surgical, Inc.
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A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K042458) manufactured by A.M. Surgical, 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 6, 2004. Regulation: 8.