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U.S. Department of Health and Human Services

Product Classification

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Device finger semi-constrained pyrolytic carbon uncemented prosthesis
Definition Pma approved: p000057.
Review Panel Orthopedic
Product CodeNEG
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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