FDA 510(k)

齊默比奧美通用導航系統

K 號：K190556 · 2019-10-24

決定日期2019-10-24

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

Zimmer Biomet Universal Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K190556. 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 Zimmer Biomet Universal Navigation System?

Zimmer Biomet Universal Navigation System is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Zimmer Biomet Spine, Inc.. The 510(k) number is K190556.

When did Zimmer Biomet Universal Navigation System receive FDA 510(k) clearance?

Zimmer Biomet Universal Navigation System received FDA 510(k) clearance on 2019-10-24, under 510(k) number K190556.

Who is the listed applicant for Zimmer Biomet Universal Navigation System?

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

What is the FDA product code for Zimmer Biomet Universal Navigation System?

The FDA product code for Zimmer Biomet Universal Navigation System is OLO.

其他以 Zimmer Biomet Spine, Inc. 為申請人之記錄

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相關器械（代碼：OLO）

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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