FDA 510(k)

脊椎導航軟體，Stryker Q導航系統

K 號：K220593 · 2022-05-27

決定日期2022-05-27

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

Spine Guidance Software, Stryker Q Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K220593. 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 Spine Guidance Software, Stryker Q Guidance System?

Spine Guidance Software, Stryker Q Guidance System is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K220593.

When did Spine Guidance Software, Stryker Q Guidance System receive FDA 510(k) clearance?

Spine Guidance Software, Stryker Q Guidance System received FDA 510(k) clearance on 2022-05-27, under 510(k) number K220593.

Who is the listed applicant for Spine Guidance Software, Stryker Q Guidance System?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spine Guidance Software, Stryker Q Guidance System?

The FDA product code for Spine Guidance Software, Stryker Q Guidance System is OLO.

其他以 Stryker Leibinger GmbH & Co KG 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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