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U.S. Department of Health and Human Services

Product Classification
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Device filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunion
Definition Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics.
Physical State protein solution-soaked colagen sponge or putty containing collagen and protein
Technical Method used as a substitute for autograft when autograft harvesting is nt possible or not feasible
Target Area long bones, e.g., tibia
Review Panel Orthopedic
Product CodeOKD
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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