PBI
- 产品代码
- PBI
- 器械名称
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3310
- 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 历史累计 510(k)
- 2 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
FDA 官方分类页： PBI
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。