FDA 510(k)

SternaFuse Ti 固定系統

K 號：K252661 · 2025-11-19

決定日期2025-11-19

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

SternaFuse Ti 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 2025-11-19 under 510(k) number K252661. 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 Ti Fixation System?

SternaFuse Ti Fixation System is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Fusion Innovations, LLC. The 510(k) number is K252661.

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

SternaFuse Ti Fixation System received FDA 510(k) clearance on 2025-11-19, under 510(k) number K252661.

Who is the listed applicant for SternaFuse Ti 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 Ti Fixation System?

The FDA product code for SternaFuse Ti Fixation System is HRS.

其他以 Fusion Innovations, LLC 為申請人之記錄

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K202914SternaFuse 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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