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Depuy Spine, Inc.
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HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 is an FDA 510(k)-cleared medical device (K081758) 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 September 2, 2008. Regulation: 8.