K231873
- 510(k) 号
- K231873
- 器械名称
- DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional
- 申请人
- Depuy Ireland UC IE
- 产品代码
- MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal
- 批准日期
- 2024-01-19
- 受理日期
- 2023-06-26
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- Orthopedic
FDA 官方记录: K231873
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。