FDA 510(k)

邊界前腰椎支撐板

K 號：K173091 · 2017-12-06

決定日期2017-12-06

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Boundary Anterior Lumbar Buttress Plate 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 2017-12-06 under 510(k) number K173091. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Boundary Anterior Lumbar Buttress Plate?

Boundary Anterior Lumbar Buttress Plate is a medical device that received FDA 510(k) clearance on 2017-12-06. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K173091.

When did Boundary Anterior Lumbar Buttress Plate receive FDA 510(k) clearance?

Boundary Anterior Lumbar Buttress Plate received FDA 510(k) clearance on 2017-12-06, under 510(k) number K173091.

Who is the listed applicant for Boundary Anterior Lumbar Buttress Plate?

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 Boundary Anterior Lumbar Buttress Plate?

The FDA product code for Boundary Anterior Lumbar Buttress Plate is KWQ.

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 K182949Healix™ 压縮螺釘系統 K180458FOCUS脊椎螺釘系統 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：KWQ）

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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官方來源

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