FDA 510(k)

Altus Spine Sochi OCT 腰椎系統

K 號：K210887 · 2021-08-20

決定日期2021-08-20

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Altus Spine Sochi OCT Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Altus Partners, LLC. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K210887. 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 Altus Spine Sochi OCT Spinal System?

Altus Spine Sochi OCT Spinal System is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Altus Partners, LLC. The 510(k) number is K210887.

When did Altus Spine Sochi OCT Spinal System receive FDA 510(k) clearance?

Altus Spine Sochi OCT Spinal System received FDA 510(k) clearance on 2021-08-20, under 510(k) number K210887.

Who is the listed applicant for Altus Spine Sochi OCT Spinal System?

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

What is the FDA product code for Altus Spine Sochi OCT Spinal System?

The FDA product code for Altus Spine Sochi OCT Spinal System is NKG.

其他以 Altus Partners, 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。

K243419Altus Spine 導航系統 K211027Altus Spine 椎弓釘系統 K211837Altus Spine 間融合獨立系統 K200922Altus Spine HA 椎弓釘系統 K200322Altus Spine 椎弓釘系統 K183084富士脊椎板系統

查看所有 16 項裝置 →

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。