K240830

Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System

510(k) 号: K240830
器械名称: Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System
申请人: Orthofix Medical, Inc. TX · US
产品代码: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
批准日期: 2024-06-20
受理日期: 2024-03-26
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Orthopedic

510(k) Summary（FDA 官方 PDF）： K240830.pdf

FDA 官方记录： K240830

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。