K240846

CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement

510(k) 号: K240846
器械名称: CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
申请人: CarboFix Orthopedics , Ltd. IL
产品代码: NKB — Thoracolumbosacral Pedicle Screw System
批准日期: 2024-04-25
受理日期: 2024-03-27
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Orthopedic

PDF下载 510(k) Summary本站存档 · 2.3 MB · FDA 公有领域文件

也可从 FDA 官方下载： K240846.pdf

FDA 官方记录： K240846

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。