FDA 510(k)

多羅米特前頸穩定系統

K 號：K202065 · 2020-10-26

決定日期2020-10-26

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

DOLOMITE Anterior Cervical Stabilization 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 2020-10-26 under 510(k) number K202065. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DOLOMITE Anterior Cervical Stabilization System?

DOLOMITE Anterior Cervical Stabilization System is a medical device that received FDA 510(k) clearance on 2020-10-26. The listed applicant is Astura Medical, LLC. The 510(k) number is K202065.

When did DOLOMITE Anterior Cervical Stabilization System receive FDA 510(k) clearance?

DOLOMITE Anterior Cervical Stabilization System received FDA 510(k) clearance on 2020-10-26, under 510(k) number K202065.

Who is the listed applicant for DOLOMITE Anterior Cervical Stabilization 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 DOLOMITE Anterior Cervical Stabilization System?

The FDA product code for DOLOMITE Anterior Cervical Stabilization System is OVE.

其他以 Astura Medical, LLC 為申請人之記錄

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相關器械（代碼：OVE）

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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