FDA 510(k)

MotoCLIP/HiMAX 嵌入系統

K 號：K181410 · 2018-06-29

決定日期2018-06-29

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

MotoCLIP/HiMAX Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2018-06-29 under 510(k) number K181410. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MotoCLIP/HiMAX Implant System?

MotoCLIP/HiMAX Implant System is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is Crossroads Extremity Systems, LLC. The 510(k) number is K181410.

When did MotoCLIP/HiMAX Implant System receive FDA 510(k) clearance?

MotoCLIP/HiMAX Implant System received FDA 510(k) clearance on 2018-06-29, under 510(k) number K181410.

Who is the listed applicant for MotoCLIP/HiMAX Implant System?

The FDA 510(k) record lists Crossroads Extremity Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MotoCLIP/HiMAX Implant System?

The FDA product code for MotoCLIP/HiMAX Implant System is JDR.

其他以 Crossroads Extremity Systems, LLC 為申請人之記錄

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相關器械（代碼：JDR）

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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