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U.S. Department of Health and Human Services

Product Classification

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Device filler, bone void, osteoinduction (w/o human growth factor)
Regulation Description Resorbable calcium salt bone void filler device.
Regulation Medical Specialty Orthopedic
Review Panel Physical Medicine
Product CodeMBP
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 888.3045
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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