FDA 510(k)

Reform® 即時檢測系統

K 號：K162300 · 2016-11-22

決定日期2016-11-22

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Reform® POCT System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K162300. 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 Reform® POCT System?

Reform® POCT System is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Precision Spine, Inc.. The 510(k) number is K162300.

When did Reform® POCT System receive FDA 510(k) clearance?

Reform® POCT System received FDA 510(k) clearance on 2016-11-22, under 510(k) number K162300.

Who is the listed applicant for Reform® POCT System?

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

What is the FDA product code for Reform® POCT System?

The FDA product code for Reform® POCT System is NKG.

其他以 Precision Spine, Inc. 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。

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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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