K243817

Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert

510(k) 号: K243817
器械名称: Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert
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: 2025-02-06
受理日期: 2024-12-12
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 · 2.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K243817.pdf

FDA 官方记录： K243817

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。