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U.S. Department of Health and Human Services

Product Classification

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Device filler, bone void, calcium compound
Regulation Description Resorbable calcium salt bone void filler device.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeMQV
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Restorative and Repair Devices Branch (RRDB)
Submission Type 510(k)
Regulation Number 888.3045
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA
Third Party Review Not Third Party Eligible
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