K241000

ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System;

510(k) 号: K241000
器械名称: ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System;
申请人: Depuy Ireland UC IE
产品代码: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
批准日期: 2024-07-11
受理日期: 2024-04-12
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Orthopedic

PDF下载 510(k) Summary本站存档 · 4.2 MB · FDA 公有领域文件

也可从 FDA 官方下载： K241000.pdf

FDA 官方记录： K241000

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。