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U.S. Department of Health and Human Services

Product Classification

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Device rod, fixation, intramedullary and accessories, metallic and non-collapsible
Regulation Description Intramedullary fixation rod.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNDE
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type 510(k)
Regulation Number 888.3020
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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