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FDA 510(k)

FiberTape Button

K号: K260405 · 2026-03-09

申请人Arthrex, Inc.
决定日期2026-03-09
产品代码MBI
咨询委员会OR
决定Substantially Equivalent

器械摘要

FiberTape Button is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K260405. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FiberTape Button?

FiberTape Button is a medical device that received FDA 510(k) clearance on 2026-03-09. The listed applicant is Arthrex, Inc.. The 510(k) number is K260405.

When did FiberTape Button receive FDA 510(k) clearance?

FiberTape Button received FDA 510(k) clearance on 2026-03-09, under 510(k) number K260405.

Who is the listed applicant for FiberTape Button?

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 FiberTape Button?

The FDA product code for FiberTape Button is MBI.

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列明Arthrex, Inc.为申报人的其他记录

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相关器械(代码:MBI)

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官方来源

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