OCG

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

产品代码

OCG

器械名称

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

管理类别

第 3 类（Class III）

21 CFR 条款

21 CFR 888.3410

FDA 专业组

Orthopedic

上市路径

需 PMA 上市前批准

标记

属植入器械

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。