CD HORIZON® Spinal System
K 號：K162494 · 2016-10-04
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器材摘要
CD HORIZON® Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K162494. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CD HORIZON® Spinal System?
CD HORIZON® Spinal System is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K162494.
When did CD HORIZON® Spinal System receive FDA 510(k) clearance?
CD HORIZON® Spinal System received FDA 510(k) clearance on 2016-10-04, under 510(k) number K162494.
Who is the listed applicant for CD HORIZON® Spinal System?
The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CD HORIZON® Spinal System?
The FDA product code for CD HORIZON® Spinal System is NKB.
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其他以 Medtronic Sofamor Danek USA, 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：NKB）
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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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。
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