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U.S. Department of Health and Human Services

Product Classification
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Device bone cement
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeLOD
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3027
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review Not Third Party Eligible
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