
Depuy Spine, Inc.
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MODIFICATION TO: HEALOS BONE GRAFT MATERIAL is an FDA 510(k)-cleared medical device (K043308) 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 February 15, 2005. Regulation: 8.