FDA 510(k)

PERLA® 頸胸椎後固定系統

K 號：K200571 · 2020-05-01

決定日期2020-05-01

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

PERLA® Posterior Occipito-Cervico-Thoracic Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K200571. 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 PERLA® Posterior Occipito-Cervico-Thoracic Fixation System?

PERLA® Posterior Occipito-Cervico-Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Spineart. The 510(k) number is K200571.

When did PERLA® Posterior Occipito-Cervico-Thoracic Fixation System receive FDA 510(k) clearance?

PERLA® Posterior Occipito-Cervico-Thoracic Fixation System received FDA 510(k) clearance on 2020-05-01, under 510(k) number K200571.

Who is the listed applicant for PERLA® Posterior Occipito-Cervico-Thoracic Fixation System?

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

What is the FDA product code for PERLA® Posterior Occipito-Cervico-Thoracic Fixation System?

The FDA product code for PERLA® Posterior Occipito-Cervico-Thoracic Fixation System is NKG.

其他以 Spineart 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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官方來源

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