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K242831

Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System

510(k) 号
K242831
器械名称
Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System
申请人
Howmedica Osteonics Corp., Dba Stryker Orthopaedics NJ · US
产品代码
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
批准日期
2024-12-04
受理日期
2024-09-19
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 · 1.8 MB · FDA 公有领域文件

也可从 FDA 官方下载: K242831.pdf

FDA 官方记录: K242831
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。