NVR

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

产品代码

NVR

器械名称

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

管理类别

第 3 类（Class III）

FDA 专业组

Unknown

上市路径

需 PMA 上市前批准

标记

属植入器械

该代码近三年的 510(k)

6 件

FDA 分类定义

Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion.

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）。