FDA 510(k)

ToeJack MIS Bunion System

K 號：K253423 · 2025-11-18

申請人Nvision Biomedical Technologies, Inc.

決定日期2025-11-18

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

ToeJack MIS Bunion 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 2025-11-18 under 510(k) number K253423. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ToeJack MIS Bunion System?

ToeJack MIS Bunion System is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K253423.

When did ToeJack MIS Bunion System receive FDA 510(k) clearance?

ToeJack MIS Bunion System received FDA 510(k) clearance on 2025-11-18, under 510(k) number K253423.

Who is the listed applicant for ToeJack MIS Bunion 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 ToeJack MIS Bunion System?

The FDA product code for ToeJack MIS Bunion System is HRS.

其他以 Nvision Biomedical Technologies, Inc. 為申請人之記錄

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相關器械（代碼：HRS）

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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