OJM
- 产品代码
- OJM
- 器械名称
- Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 888.3060
- FDA 专业组
- Orthopedic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
FDA 分类定义
Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.
FDA 官方分类页: OJM
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。