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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, knee, hemi-, femoral
Regulation Description Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeHSA
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Regulation Number 888.3570
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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