QAC
- 产品代码
- QAC
- 器械名称
- Screw Sleeve Bone Fixation Device
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3043
- 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
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.
FDA 官方分类页： QAC
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。