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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
Definition Device type: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction, revision spine surgery, autograft not available or feasible - replacement for autograft bone in patients where autograft is unavailable or not feasible to harvest. Not feasible to harvest is intended to means presence of a condition where normal bone metabolism would be expected to prevent healing, e.G., smokers and diabetics. Revision spine surgery to treat pseudarthrosis.
Physical State none
Technical Method Product provides signal for cell differentiation and scaffold for new bone growth
Target Area spine
Review Panel Orthopedic
Product CodeOJZ
Premarket Review Orthopedic Devices (OHT6)
Stereotaxic, Trauma and Restorative 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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