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U.S. Department of Health and Human Services

Product Classification

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Device filler, bone void, synthetic peptide
Definition The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone.
Review Panel Orthopedic
Product CodeNOX
Premarket Review Stereotaxic, Trauma and Restorative Devices (DHT6C)
Stereotaxic, Trauma and Restorative Devices (DHT6C)
Submission Type Contact ODE
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible