FDA 510(k)

DSG螺紋鑽孔系統

K 號：K152747 · 2016-06-10

決定日期2016-06-10

產品代碼PDQ

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

DSG Threaded Drill 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 2016-06-10 under 510(k) number K152747. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DSG Threaded Drill System?

DSG Threaded Drill System is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Spineguard S.A.. The 510(k) number is K152747.

When did DSG Threaded Drill System receive FDA 510(k) clearance?

DSG Threaded Drill System received FDA 510(k) clearance on 2016-06-10, under 510(k) number K152747.

Who is the listed applicant for DSG Threaded Drill 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 DSG Threaded Drill System?

The FDA product code for DSG Threaded Drill System is PDQ.

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 K162884脊椎保護DSG Zavation螺釘系統

相關器械（代碼：PDQ）

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。

K260992iD3 航向解壓探針 (NTX-9005)；iD3 球頭刺激探針 (NTX-9006)；iD3 航向球頭探針 (NTX-9007)Neuralytix K253580無菌隔離擴張器，5、10、16mm（MDT-0442S）；无菌隔離擴張器，20mm（MDT-0469S）Tedan Surgical Innovations K243636神經立體 iD3 系統（NTX-9001）Neuralytix, LLC K223438TELIKEN系統周邊神經刺激器適應症Medos International SARL K221821ATEC IOM 擴充儀器Alphatec Spine, Inc.K220160PediGuard 穿釘式Spineguard S.A.

官方來源

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