
Biomedics
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THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY is an FDA 510(k)-cleared medical device (K972463) manufactured by Biomedics. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 1997. Regulation: 8.