FDA 510(k)

威爾特羅姆脊椎固定系統

K 號：K172548 · 2018-01-12

決定日期2018-01-12

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Wiltrom Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Wiltrom Corporation Limited. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K172548. 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 Wiltrom Spinal Fixation System?

Wiltrom Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Wiltrom Corporation Limited. The 510(k) number is K172548.

When did Wiltrom Spinal Fixation System receive FDA 510(k) clearance?

Wiltrom Spinal Fixation System received FDA 510(k) clearance on 2018-01-12, under 510(k) number K172548.

Who is the listed applicant for Wiltrom Spinal Fixation System?

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

What is the FDA product code for Wiltrom Spinal Fixation System?

The FDA product code for Wiltrom Spinal Fixation System is NKB.

其他以 Wiltrom Corporation Limited 為申請人之記錄

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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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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