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FDA 510(k)

FlareHawk 間隙融合系統

K 號：K243116 · 2025-05-21

申請人Integrity Implants Inc. Dba Accelus
決定日期2025-05-21
產品代碼MAX
諮詢委員會或
決定相當於

器材摘要

FlareHawk Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Integrity Implants Inc. Dba Accelus. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K243116. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FlareHawk Interbody Fusion System?

FlareHawk Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Integrity Implants Inc. Dba Accelus. The 510(k) number is K243116.

When did FlareHawk Interbody Fusion System receive FDA 510(k) clearance?

FlareHawk Interbody Fusion System received FDA 510(k) clearance on 2025-05-21, under 510(k) number K243116.

Who is the listed applicant for FlareHawk Interbody Fusion System?

The FDA 510(k) record lists Integrity Implants Inc. Dba Accelus as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlareHawk Interbody Fusion System?

The FDA product code for FlareHawk Interbody Fusion System is MAX.

相關臨床試驗

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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相關器械（代碼：MAX）

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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