FDA 510(k)

Palisade脊椎固定系統

K 號：K153323 · 2016-02-23

決定日期2016-02-23

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Palisade Pedicular Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K153323. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Palisade Pedicular Fixation System?

Palisade Pedicular Fixation System is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Spineology, Inc.. The 510(k) number is K153323.

When did Palisade Pedicular Fixation System receive FDA 510(k) clearance?

Palisade Pedicular Fixation System received FDA 510(k) clearance on 2016-02-23, under 510(k) number K153323.

Who is the listed applicant for Palisade Pedicular Fixation System?

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

What is the FDA product code for Palisade Pedicular Fixation System?

The FDA product code for Palisade Pedicular Fixation System is NKB.

其他以 Spineology, Inc. 為申請人之記錄

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相關器械（代碼：NKB）

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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