FDA 510(k)

Q導向系統；Mako脊椎系統；

K 號：K241517 · 2024-08-27

決定日期2024-08-27

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

Q Guidance System; Mako Spine 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 2024-08-27 under 510(k) number K241517. 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 Q Guidance System; Mako Spine System;?

Q Guidance System; Mako Spine System; is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K241517.

When did Q Guidance System; Mako Spine System; receive FDA 510(k) clearance?

Q Guidance System; Mako Spine System; received FDA 510(k) clearance on 2024-08-27, under 510(k) number K241517.

Who is the listed applicant for Q Guidance System; Mako Spine 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 Q Guidance System; Mako Spine System;?

The FDA product code for Q Guidance System; Mako Spine 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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