FDA 510(k)

SternaFuse 固定系統

K 號：K202914 · 2022-01-26

決定日期2022-01-26

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

SternaFuse Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Innovations, LLC. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K202914. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SternaFuse Fixation System?

SternaFuse Fixation System is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Fusion Innovations, LLC. The 510(k) number is K202914.

When did SternaFuse Fixation System receive FDA 510(k) clearance?

SternaFuse Fixation System received FDA 510(k) clearance on 2022-01-26, under 510(k) number K202914.

Who is the listed applicant for SternaFuse Fixation System?

The FDA 510(k) record lists Fusion Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SternaFuse Fixation System?

The FDA product code for SternaFuse Fixation System is HRS.

其他以 Fusion Innovations, LLC 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。

K252661SternaFuse Ti 固定系統

相關器械（代碼：HRS）

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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