FDA 510(k)

Cortina™ [MAX] 腰椎籠架系統

K 號：K192248 · 2019-11-25

決定日期2019-11-25

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Cortina™ [MAX] Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Neurostructures, Inc.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K192248. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cortina™ [MAX] Lumbar Cage System?

Cortina™ [MAX] Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Neurostructures, Inc.. The 510(k) number is K192248.

When did Cortina™ [MAX] Lumbar Cage System receive FDA 510(k) clearance?

Cortina™ [MAX] Lumbar Cage System received FDA 510(k) clearance on 2019-11-25, under 510(k) number K192248.

Who is the listed applicant for Cortina™ [MAX] Lumbar Cage System?

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

What is the FDA product code for Cortina™ [MAX] Lumbar Cage System?

The FDA product code for Cortina™ [MAX] Lumbar Cage System is MAX.

其他以 Neurostructures, Inc. 為申請人之記錄

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相關器械（代碼：MAX）

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

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