
Bioplate, Inc.
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STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K022033) 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 July 18, 2002. Regulation: 8.