
Kinetikos Medical, Inc.
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K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) is an FDA 510(k)-cleared medical device (K023770) manufactured by Kinetikos Medical, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 11, 2002. Regulation: 8.