IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM

IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM is an FDA 510(k)-cleared medical device (K921854) manufactured by Impla-Med. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 1992. Regulation: 8.