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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, knee, hemi-, patellar resurfacing, uncemented
Regulation Description Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeHTG
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 888.3580
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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