LOF

Stimulator, Bone Growth, Non-Invasive

产品代码: LOF
器械名称: Stimulator, Bone Growth, Non-Invasive
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 890.5870
FDA 专业组: Orthopedic
上市路径: 需提交 510(k) 上市前通告

FDA 分类定义

A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference: www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

FDA 官方分类页： LOF

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。