FDA 510(k)

DePuy Synthes 颌面外科产品组合 - MR 条件

K号: K183113 · 2019-03-13

决定日期2019-03-13

产品代码MQN

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决定实质等同

器械摘要

DePuy Synthes Maxillofacial Portfolio - MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K183113. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DePuy Synthes Maxillofacial Portfolio - MR Conditional?

DePuy Synthes Maxillofacial Portfolio - MR Conditional is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K183113.

When did DePuy Synthes Maxillofacial Portfolio - MR Conditional receive FDA 510(k) clearance?

DePuy Synthes Maxillofacial Portfolio - MR Conditional received FDA 510(k) clearance on 2019-03-13, under 510(k) number K183113.

Who is the listed applicant for DePuy Synthes Maxillofacial Portfolio - MR Conditional?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes Maxillofacial Portfolio - MR Conditional?

The FDA product code for DePuy Synthes Maxillofacial Portfolio - MR Conditional is MQN.

列明Synthes (USA) Products, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254087MAXFRAME AUTOSTRUT™ 带蓝牙多轴向校正系统 K212943SyntheCel Dura Repair K211313MAXFRAME 多轴向校正系统（又称 MAXFRAME）K210408DePuy Synthes 可变角度锁定髌骨钢板系统 K210205DePuy Synthes 3.5/4.5 mm 可变角度 LCP 假体近端股骨板系统 K201346DePuy Synthes 逆行股骨钉高级系统，DePuy Synthes 骨髓钉锁定螺钉，5.0 毫米

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