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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
Regulation Description Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeJDH
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Regulation Number 888.3380
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
Guidance Document
Third Party Review Not Third Party Eligible
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