FDA 510(k)

纖維鎖植入物；纖維鎖儀器；纖維鎖功率單元

K 號：K253867 · 2026-01-02

決定日期2026-01-02

產品代碼OWX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is the device name listed in this FDA 510(k) record. The listed applicant is ZuriMED Technologies AG. It received FDA 510(k) clearance on 2026-01-02 under 510(k) number K253867. The device is classified under product code OWX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is a medical device that received FDA 510(k) clearance on 2026-01-02. The listed applicant is ZuriMED Technologies AG. The 510(k) number is K253867.

When did FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit receive FDA 510(k) clearance?

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit received FDA 510(k) clearance on 2026-01-02, under 510(k) number K253867.

Who is the listed applicant for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

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

What is the FDA product code for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

The FDA product code for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is OWX.

其他以 ZuriMED Technologies AG 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。

K241219FiberLocker 系統：FiberLocker 偽裝植入物（SpeedPatch PET），FiberLocker 應用工具（FiberLocker 應用工具 SN）

相關器械（代碼：OWX）

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。

K250997Integrity™ 嵌入式設備Anika Therapeutics, Inc.K243480縫合補片組織增強劑Arthrex, Inc.K241219FiberLocker 系統：FiberLocker 偽裝植入物（SpeedPatch PET），FiberLocker 應用工具（FiberLocker 應用工具 SN）ZuriMED Technologies AG K223538整潔植入體Anika Therapeutics, Inc.

官方來源

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