FDA 510(k)

DePuy Synthes 頭顎外科產品系列 - MR條件性

K 號：K183113 · 2019-03-13

決定日期2019-03-13

產品代碼MQN

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Synthes (USA) Products, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：MQN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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