
Mathys Corp. of North America
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HA-TI (HAND-TITANIUM SCREW) IMPLANT is an FDA 510(k)-cleared medical device (K901927) manufactured by Mathys Corp. of North America. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 3, 1991. Regulation: 8.