FDA 510(k)

VEOFIX 快拆螺釘

K 號：K253108 · 2026-06-05

決定日期2026-06-05

產品代碼HWC

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器材摘要

VEOFIX Snap Off Screw is the device name listed in this FDA 510(k) record. The listed applicant is Steps Ortho. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K253108. 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

What is the VEOFIX Snap Off Screw?

VEOFIX Snap Off Screw is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Steps Ortho. The 510(k) number is K253108.

When did VEOFIX Snap Off Screw receive FDA 510(k) clearance?

VEOFIX Snap Off Screw received FDA 510(k) clearance on 2026-06-05, under 510(k) number K253108.

Who is the listed applicant for VEOFIX Snap Off Screw?

FDA 510(k) 記錄將 Steps Ortho 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for VEOFIX Snap Off Screw?

The FDA product code for VEOFIX Snap Off Screw is HWC. This falls under the Cardiovascular category.

其他以 Steps Ortho 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。

K254280F.A.S.T. 螺釘

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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