
Bioplate, Inc.
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MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY is an FDA 510(k)-cleared medical device (K022890) manufactured by Bioplate, Inc.. 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 5, 2002. Regulation: 8.