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U.S. Department of Health and Human Services

Product Classification
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Device filler, bone void, calcium compound, lower extremity use, use on bone marrow lesions
Definition Intended to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure. These defects may be surgically created from traumatic injury to the bone including bone marrow lesions.
Physical State Various (including granules, pre-formed blocks, putties, pastes, and gels)
Technical Method The implanted bone void filler device resorbs and is replaced with bone during the healing process.
Target Area Lower extremities (pelvis through foot)
Review Panel Orthopedic
Product CodeQCG
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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