FDA 510(k)

HALF DOME 背部腰椎間植入系統

K 號：K182877 · 2019-05-03

決定日期2019-05-03

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

HALF DOME Posterior Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical, LLC. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K182877. 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 HALF DOME Posterior Lumbar Interbody System?

HALF DOME Posterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Astura Medical, LLC. The 510(k) number is K182877.

When did HALF DOME Posterior Lumbar Interbody System receive FDA 510(k) clearance?

HALF DOME Posterior Lumbar Interbody System received FDA 510(k) clearance on 2019-05-03, under 510(k) number K182877.

Who is the listed applicant for HALF DOME Posterior Lumbar Interbody System?

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

What is the FDA product code for HALF DOME Posterior Lumbar Interbody System?

The FDA product code for HALF DOME Posterior Lumbar Interbody System is MAX.

其他以 Astura Medical, LLC 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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