FDA 510(k)

SnapHammer 間趾調整系統

K 號：K250613 · 2025-04-02

申請人Nvision Biomedical Technologies, Inc.

決定日期2025-04-02

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

SnapHammer Hammertoe Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K250613. 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 SnapHammer Hammertoe Correction System?

SnapHammer Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K250613.

When did SnapHammer Hammertoe Correction System receive FDA 510(k) clearance?

SnapHammer Hammertoe Correction System received FDA 510(k) clearance on 2025-04-02, under 510(k) number K250613.

Who is the listed applicant for SnapHammer Hammertoe Correction System?

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

What is the FDA product code for SnapHammer Hammertoe Correction System?

The FDA product code for SnapHammer Hammertoe Correction System is HWC. This falls under the Cardiovascular category.

其他以 Nvision Biomedical Technologies, 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。

K253718提升PEEK趾骨系統 K260291Vortex5 尖鈎趾修復系統 K253423ToeJack MIS Bunion System K252657影響 PEEK 聯合釘系統 K2402503D打印PEEK間置系統 K231453SnapHammer 間趾調整系統

查看所有 24 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。