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FDA 510(k)

Arthrex FiberTak Suture Anchor

K 號：K260561 · 2026-03-20

申請人Arthrex, Inc.
決定日期2026-03-20
產品代碼MBI
諮詢委員會OR
決定Substantially Equivalent

器材摘要

Arthrex FiberTak Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K260561. 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 Arthrex FiberTak Suture Anchor?

Arthrex FiberTak Suture Anchor is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Arthrex, Inc.. The 510(k) number is K260561.

When did Arthrex FiberTak Suture Anchor receive FDA 510(k) clearance?

Arthrex FiberTak Suture Anchor received FDA 510(k) clearance on 2026-03-20, under 510(k) number K260561.

Who is the listed applicant for Arthrex FiberTak Suture Anchor?

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

What is the FDA product code for Arthrex FiberTak Suture Anchor?

The FDA product code for Arthrex FiberTak Suture Anchor is MBI.

相關臨床試驗

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其他以 Arthrex, Inc. 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。

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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。

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

官方來源

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