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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
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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