FDA 510(k)

SINEFIX

K 號：K254176 · 2026-03-16

決定日期2026-03-16

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

SINEFIX is the device name listed in this FDA 510(k) record. The listed applicant is BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K254176. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SINEFIX?

SINEFIX is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is BAAT Medical Products B.V.. The 510(k) number is K254176.

When did SINEFIX receive FDA 510(k) clearance?

SINEFIX received FDA 510(k) clearance on 2026-03-16, under 510(k) number K254176.

Who is the listed applicant for SINEFIX?

The FDA 510(k) record lists BAAT Medical Products B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINEFIX?

The FDA product code for SINEFIX is MBI.

其他以 BAAT Medical Products B.V. 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。

K251961SDS成長桿 K220966SINEFIX K211474kleiner KG2 系統 K201830ANSER 離開肩釘

相關器械（代碼：MBI）

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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