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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 Restorative, Repair and Trauma Devices (DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3045
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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