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U.S. Department of Health and Human Services

Product Classification

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Device spinal pedicle screw, fixation, appliance system
Review Panel Orthopedic
Product CodeMCV
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Posterior Spine Devices Branch (PSDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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