FDA 510(k)

Healix™ 压縮螺釘系統

K 號：K182949 · 2018-12-04

決定日期2018-12-04

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Healix™ Compression Screw 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 2018-12-04 under 510(k) number K182949. 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 Healix™ Compression Screw System?

Healix™ Compression Screw System is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K182949.

When did Healix™ Compression Screw System receive FDA 510(k) clearance?

Healix™ Compression Screw System received FDA 510(k) clearance on 2018-12-04, under 510(k) number K182949.

Who is the listed applicant for Healix™ Compression Screw 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 Healix™ Compression Screw System?

The FDA product code for Healix™ Compression Screw 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 K183055向量 hammertoe 矫正系統 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。

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

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