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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Regulation Description Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWY
Premarket Review Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3390
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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