K232303

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

510(k) 号
K232303
器械名称
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology
申请人
Depuy Ireland UC IE
产品代码
MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constra
批准日期
2023-12-11
受理日期
2023-08-01
决定
Substantially Equivalent
审查途径
Traditional
咨询委员会
Orthopedic
510(k) Summary(FDA 官方 PDF): K232303.pdf
FDA 官方记录: K232303
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。