FDA 510(k)

博洛按鈕系統

K 號：K242091 · 2024-12-23

決定日期2024-12-23

產品代碼HTN

諮詢委員會或

決定相當於

器材摘要

Bolo Button System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K242091. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bolo Button System?

Bolo Button System is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Fusion Orthopedics. The 510(k) number is K242091.

When did Bolo Button System receive FDA 510(k) clearance?

Bolo Button System received FDA 510(k) clearance on 2024-12-23, under 510(k) number K242091.

Who is the listed applicant for Bolo Button System?

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

What is the FDA product code for Bolo Button System?

The FDA product code for Bolo Button System is HTN.

其他以 Fusion Orthopedics 為申請人之記錄

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K211843PolyLock 鍊接系統

相關器械（代碼：HTN）

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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