FDA 510(k)

脊椎保護DSG Zavation螺釘系統

K 號：K162884 · 2017-01-12

決定日期2017-01-12

產品代碼HBG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

SpineGuard DSG Zavation Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Spineguard S.A.. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K162884. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SpineGuard DSG Zavation Screw System?

SpineGuard DSG Zavation Screw System is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Spineguard S.A.. The 510(k) number is K162884.

When did SpineGuard DSG Zavation Screw System receive FDA 510(k) clearance?

SpineGuard DSG Zavation Screw System received FDA 510(k) clearance on 2017-01-12, under 510(k) number K162884.

Who is the listed applicant for SpineGuard DSG Zavation Screw System?

The FDA 510(k) record lists Spineguard S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpineGuard DSG Zavation Screw System?

The FDA product code for SpineGuard DSG Zavation Screw System is HBG.

其他以 Spineguard S.A. 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。

K220160PediGuard 穿釘式 K201454DSG Connect Technology K152747DSG螺紋鑽孔系統

相關器械（代碼：HBG）

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。

K252696遺留設備名稱醫療設備規範文本 (保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址) 政策：醫療規範-v1 返回僅翻譯內容 LEGACYPhasor Health, LLC K153587針對可吸收螺釘的設備名稱Synthes (USA) Products, LLC K160129MRII 頭蓋骨钻及附件Mri Interventions, Inc.

官方來源

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