FDA 510(k)

索拉纳斯® 頸後部OCT固定系統

K 號：K191185 · 2019-06-03

決定日期2019-06-03

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Solanas® Posterior OCT Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine. It received FDA 510(k) clearance on 2019-06-03 under 510(k) number K191185. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Solanas® Posterior OCT Fixation System?

Solanas® Posterior OCT Fixation System is a medical device that received FDA 510(k) clearance on 2019-06-03. The listed applicant is Alphatec Spine. The 510(k) number is K191185.

When did Solanas® Posterior OCT Fixation System receive FDA 510(k) clearance?

Solanas® Posterior OCT Fixation System received FDA 510(k) clearance on 2019-06-03, under 510(k) number K191185.

Who is the listed applicant for Solanas® Posterior OCT Fixation System?

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

What is the FDA product code for Solanas® Posterior OCT Fixation System?

The FDA product code for Solanas® Posterior OCT Fixation System is NKG.

其他以 Alphatec Spine 為申請人之記錄

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相關器械（代碼：NKG）

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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