FDA 510(k)

Vector® 鐵腳趾矯正系統

K 號：K213421 · 2021-11-19

申請人Nvision Biomedical Technologies, Inc.

決定日期2021-11-19

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Vector® 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 2021-11-19 under 510(k) number K213421. 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 Vector® Hammertoe Correction System?

Vector® Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K213421.

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

Vector® Hammertoe Correction System received FDA 510(k) clearance on 2021-11-19, under 510(k) number K213421.

Who is the listed applicant for Vector® 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 Vector® Hammertoe Correction System?

The FDA product code for Vector® 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

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相關器械（代碼：HWC）

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