FDA 510(k)

ANAX™ OCT 脊柱系統

K 號：K183383 · 2018-12-12

決定日期2018-12-12

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

ANAX™ OCT Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2018-12-12 under 510(k) number K183383. 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 ANAX™ OCT Spinal System?

ANAX™ OCT Spinal System is a medical device that received FDA 510(k) clearance on 2018-12-12. The listed applicant is U&I Corporation. The 510(k) number is K183383.

When did ANAX™ OCT Spinal System receive FDA 510(k) clearance?

ANAX™ OCT Spinal System received FDA 510(k) clearance on 2018-12-12, under 510(k) number K183383.

Who is the listed applicant for ANAX™ OCT Spinal System?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANAX™ OCT Spinal System?

The FDA product code for ANAX™ OCT Spinal System is NKG.

其他以 U&I Corporation 為申請人之記錄

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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

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