FDA 510(k)

Arthrex Beaming系統

K 號：K254215 · 2026-05-08

決定日期2026-05-08

產品代碼HWC

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決定相當於

器材摘要

Arthrex Beaming System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K254215. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

什麼是Arthrex Beaming System？

Arthrex Beaming System is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Arthrex, Inc.. The 510(k) number is K254215.

Arthrex Beaming System 何時獲得 FDA 510(k) 許可？

Arthrex Beaming System received FDA 510(k) clearance on 2026-05-08, under 510(k) number K254215.

誰是Arthrex Beaming System的列名申請人？

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。

Arthrex Beaming System 的 FDA 產品代碼是什麼？

FDA產品代碼為Arthrex Beaming System的是HWC。這屬於心血管類別。

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：HWC）

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。

K262975Arthrex Beaming系統Arthrex, Inc.K260995DynaNail螺旋®固定系統MedShape, Inc.K254280F.A.S.T. 螺釘Steps Ortho K261057ActivaScrew™ 穿刺式 COMBioretec, Ltd.K260106OsteoCoil™ GT 活動壓縮系統Flower Orthopedics Corporation DBA Conventus Flower Orthoped K262344大型壓縮螺釘TriMed, Inc.

官方來源

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