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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 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
Guidance Documents
  • Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA
  • Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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