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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
Review Panel Orthopedic
Product CodeJDH
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Not Classified Reason IDE
Submission Type PMA
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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