FDA 510(k)

G外科脊椎系統光學斷層掃描儀

K 號：K171834 · 2017-12-19

決定日期2017-12-19

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

G Surgical OCT Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is G Surgical, LLC. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K171834. 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 G Surgical OCT Spinal System?

G Surgical OCT Spinal System is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is G Surgical, LLC. The 510(k) number is K171834.

When did G Surgical OCT Spinal System receive FDA 510(k) clearance?

G Surgical OCT Spinal System received FDA 510(k) clearance on 2017-12-19, under 510(k) number K171834.

Who is the listed applicant for G Surgical OCT Spinal System?

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

What is the FDA product code for G Surgical OCT Spinal System?

The FDA product code for G Surgical OCT Spinal System is NKG.

其他以 G Surgical, 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。

K240737G外科精準手術系統 K230063G外科精準手術脊椎變形系統 K210890GPS頸椎間隔器 K193219G外科標誌系統 K161516G外科精準手術系統

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。