FDA 510(k)

iASSIST 適合膝關節系統

K 號：K192080 · 2019-11-05

決定日期2019-11-05

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

iASSIST Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K192080. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iASSIST Knee System?

iASSIST Knee System is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K192080.

When did iASSIST Knee System receive FDA 510(k) clearance?

iASSIST Knee System received FDA 510(k) clearance on 2019-11-05, under 510(k) number K192080.

Who is the listed applicant for iASSIST Knee System?

The FDA 510(k) record lists Orthosoft Inc (D/B/A Zimmer Cas) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iASSIST Knee System?

The FDA product code for iASSIST Knee System is OLO.

其他以 Orthosoft Inc (D/B/A Zimmer Cas) 為申請人之記錄

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