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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 Orthopedic Devices (OHT6)
Stereotaxic, Trauma and Restorative 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
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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