K241466

Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System

510(k) 号: K241466
器械名称: Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System
申请人: SeaSpine Orthopedics Corporation CA · US
产品代码: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
批准日期: 2024-06-20
受理日期: 2024-05-23
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 · 3.3 MB · FDA 公有领域文件

也可从 FDA 官方下载： K241466.pdf

FDA 官方记录： K241466

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。