
Depuy Spine, Inc.
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HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K062495) manufactured by Depuy Spine, 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 October 12, 2006. Regulation: 8.