FDA 510(k)

TriMAX 嵌入式系統

K 號：K190722 · 2019-08-16

決定日期2019-08-16

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

TriMAX Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extemity Systems, LLC. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K190722. 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 TriMAX Implant System?

TriMAX Implant System is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Crossroads Extemity Systems, LLC. The 510(k) number is K190722.

When did TriMAX Implant System receive FDA 510(k) clearance?

TriMAX Implant System received FDA 510(k) clearance on 2019-08-16, under 510(k) number K190722.

Who is the listed applicant for TriMAX Implant System?

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

What is the FDA product code for TriMAX Implant System?

The FDA product code for TriMAX Implant System is JDR.

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

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