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FDA 510(k)

北欧腰椎多軸螺釘系統

K 號:K180655 · 2018-07-13

決定日期2018-07-13
產品代碼NKB
諮詢委員會或
決定相當於

器材摘要

Viking Lumbar Polyaxial Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Presidio Surgical. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K180655. 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 Viking Lumbar Polyaxial Screw System?

Viking Lumbar Polyaxial Screw System is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Presidio Surgical. The 510(k) number is K180655.

When did Viking Lumbar Polyaxial Screw System receive FDA 510(k) clearance?

Viking Lumbar Polyaxial Screw System received FDA 510(k) clearance on 2018-07-13, under 510(k) number K180655.

Who is the listed applicant for Viking Lumbar Polyaxial Screw System?

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

What is the FDA product code for Viking Lumbar Polyaxial Screw System?

The FDA product code for Viking Lumbar Polyaxial Screw System is NKB.

相關臨床試驗

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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。

官方來源

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