FDA 510(k)

向量 hammertoe 矫正系統

K 號：K183055 · 2019-02-19

決定日期2019-02-19

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, LLC. It received FDA 510(k) clearance on 2019-02-19 under 510(k) number K183055. 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 2019-02-19. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K183055.

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

Vector Hammertoe Correction System received FDA 510(k) clearance on 2019-02-19, under 510(k) number K183055.

Who is the listed applicant for Vector Hammertoe Correction System?

The FDA 510(k) record lists Nvision Biomedical Technologies, LLC 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, LLC 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。

K182943VERTEX 鈦金釘系統 K182949Healix™ 压縮螺釘系統 K180458FOCUS脊椎螺釘系統 K173091邊界前腰椎支撐板 K170074nvc (注意：原文 "device_name medical-device regulatory text" 中的 "device_name" 沒有提供具體名稱，因此我將其翻譯為 "設備名稱"。若 "device_name" 是一個特定的產品名稱，則應保留原樣。以下為翻譯內容：) 設備名稱醫療設備規範文本政策：醫療規範-v1 FDA、510(k)、PMA、NCT、PMID、識別碼和網址請保持原樣。K162426nva、nvp及nvt

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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。

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