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FDA 510(k)

Oculus-SA 腰椎融合器系統

K 號:K202190 · 2020-10-02

決定日期2020-10-02
產品代碼OVD
諮詢委員會或
決定相當於

器材摘要

Oculus-SA Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Neurostructures. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K202190. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Oculus-SA Lumbar Cage System?

Oculus-SA Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Neurostructures. The 510(k) number is K202190.

When did Oculus-SA Lumbar Cage System receive FDA 510(k) clearance?

Oculus-SA Lumbar Cage System received FDA 510(k) clearance on 2020-10-02, under 510(k) number K202190.

Who is the listed applicant for Oculus-SA Lumbar Cage System?

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

What is the FDA product code for Oculus-SA Lumbar Cage System?

The FDA product code for Oculus-SA Lumbar Cage System is OVD.

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相關器械(代碼:OVD)

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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