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U.S. Department of Health and Human Services

Product Classification

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Device bone cement, antibiotic
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeMBB
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Restorative and Repair Devices Branch (RRDB)
Submission Type 510(k)
Regulation Number 888.3027
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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