FDA 510(k)

NanoOrtho NanoKnee® 系統

K 號：K190633 · 2019-12-20

決定日期2019-12-20

產品代碼HRY

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器材摘要

NanoOrtho NanoKnee® System is the device name listed in this FDA 510(k) record. The listed applicant is Nanoortho, LLC. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K190633. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NanoOrtho NanoKnee® System?

NanoOrtho NanoKnee® System is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Nanoortho, LLC. The 510(k) number is K190633.

When did NanoOrtho NanoKnee® System receive FDA 510(k) clearance?

NanoOrtho NanoKnee® System received FDA 510(k) clearance on 2019-12-20, under 510(k) number K190633.

Who is the listed applicant for NanoOrtho NanoKnee® System?

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

What is the FDA product code for NanoOrtho NanoKnee® System?

The FDA product code for NanoOrtho NanoKnee® System is HRY.

相關器械（代碼：HRY）

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器材摘要

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相關臨床試驗

相關器械（代碼：HRY）

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