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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, pelvifemoral resurfacing, metal/polymer, uncemented
Regulation Description Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
Definition Call for PMAs to be filed by 1/3/05 per 69 FR 59134 on 10/4/04 - Intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis of the femoral head.
Product CodeOCG
Regulation Number 888.3410
Device Class 3

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