KXB

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

产品代码

KXB

器械名称

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

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

Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976. Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis must have an approved pma or a declared completed pdp in effect before being placed in commercial distribution.

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）。