FDA 510(k)

Arthrex SpeedFLEX™ 假體

K 號：K251690 · 2025-09-30

決定日期2025-09-30

產品代碼OWY

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

Arthrex SpeedFLEX™ Implant is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-09-30 under 510(k) number K251690. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arthrex SpeedFLEX™ Implant?

Arthrex SpeedFLEX™ Implant is a medical device that received FDA 510(k) clearance on 2025-09-30. The listed applicant is Arthrex, Inc.. The 510(k) number is K251690.

When did Arthrex SpeedFLEX™ Implant receive FDA 510(k) clearance?

Arthrex SpeedFLEX™ Implant received FDA 510(k) clearance on 2025-09-30, under 510(k) number K251690.

Who is the listed applicant for Arthrex SpeedFLEX™ Implant?

FDA 510(k) 記錄將 Arthrex, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Arthrex SpeedFLEX™ Implant?

The FDA product code for Arthrex SpeedFLEX™ Implant is OWY.

其他以 Arthrex, Inc. 為申請人之記錄

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相關器械（代碼：OWY）

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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