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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, hip, hemi-, acetabular, cemented, metal
Regulation Description Hip joint (hemi-hip) acetabular metal cemented prosthesis.
Definition Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWB
Premarket Review Joint Arthroplasty Devices (DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Regulation Number 888.3370
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible