FDA 510(k)

NEXXT MATRIXX® SI 系統

K 號：K243838 · 2025-03-14

決定日期2025-03-14

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

NEXXT MATRIXX® SI System is the device name listed in this FDA 510(k) record. The listed applicant is Nexxt Spine. It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K243838. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NEXXT MATRIXX® SI System?

NEXXT MATRIXX® SI System is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Nexxt Spine. The 510(k) number is K243838.

When did NEXXT MATRIXX® SI System receive FDA 510(k) clearance?

NEXXT MATRIXX® SI System received FDA 510(k) clearance on 2025-03-14, under 510(k) number K243838.

Who is the listed applicant for NEXXT MATRIXX® SI System?

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

What is the FDA product code for NEXXT MATRIXX® SI System?

The FDA product code for NEXXT MATRIXX® SI System is OUR.

其他以 Nexxt Spine 為申請人之記錄

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。

K240690STRUXXURE® 頸椎前側板系統

相關器械（代碼：OUR）

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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官方來源

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