FDA 510(k)

維拉日®導航系統

K 號：K240647 · 2024-04-05

申請人Zimvie Spine (Zimmer Biomet Spine, Inc.)

決定日期2024-04-05

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

Virage® Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zimvie Spine (Zimmer Biomet Spine, Inc.). It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K240647. 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 Virage® Navigation System?

Virage® Navigation System is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Zimvie Spine (Zimmer Biomet Spine, Inc.). The 510(k) number is K240647.

When did Virage® Navigation System receive FDA 510(k) clearance?

Virage® Navigation System received FDA 510(k) clearance on 2024-04-05, under 510(k) number K240647.

Who is the listed applicant for Virage® Navigation System?

The FDA 510(k) record lists Zimvie Spine (Zimmer Biomet Spine, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Virage® Navigation System?

The FDA product code for Virage® Navigation System is OLO.

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