FDA 510(k)

Z-LINKPC 系統

K 號：K162575 · 2017-03-03

決定日期2017-03-03

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Z-LINKPC System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation, LLC. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K162575. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Z-LINKPC System?

Z-LINKPC System is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Zavation, LLC. The 510(k) number is K162575.

When did Z-LINKPC System receive FDA 510(k) clearance?

Z-LINKPC System received FDA 510(k) clearance on 2017-03-03, under 510(k) number K162575.

Who is the listed applicant for Z-LINKPC System?

The FDA 510(k) record lists Zavation, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Z-LINKPC System?

The FDA product code for Z-LINKPC System is NKG.

其他以 Zavation, 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。

K162206Zavation IBF K162824Z-Span 板系統 K161016Z-Clamp ISP系統 K153404Zavation脊椎系統 K160362Z-Span 板系統

相關器械（代碼：NKG）

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。

K254260VEGA 子宮頸螺釘系統GS Medical Co., Ltd.K253195泰魯斯後枕顱頸胸脊椎系統ZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® 頸椎後路螺釘系統；CarboClear® 混合後路螺釘系統CarboFix Orthopedics , Ltd.K254165Infinity™ 光學斷層掃描系統Medtronic Sofamor Danek USA, Inc.K252327CMORE® CT系統；CMORE® CT系統導航儀器Icotec AG K253129Infinity™ 光學斷層掃描系統Medtronic Sofamor Danek USA, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。