MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX

MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX is an FDA 510(k)-cleared medical device (K970119) manufactured by Mitek Products. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 1998. Regulation: 8.