FDA 510(k)

SnapHammer 指甲矫正システム

K番号: K250613 · 2025-04-02

申請者Nvision Biomedical Technologies, Inc.

決定日2025-04-02

製品コードHWC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてNvision Biomedical Technologies, Inc.を記載するその他の記録

K253718enHAnce PEEK Bunion System K260291Vortex5 Tailor's Bunion Correction System K253423ToeJack MIS Bunion System K252657インパクト PEEKユニオンナイルシステム K2402503DプリントされたPEEKインターボディシステム K231453SnapHammer 指甲矫正システム

すべての24件のデバイスを表示 →

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。