FDA 510(k)

救世者(R)外固定系統

K 號：K153635 · 2016-01-13

決定日期2016-01-13

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

SALVATION(R) External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K153635. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SALVATION(R) External Fixation System?

SALVATION(R) External Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K153635.

When did SALVATION(R) External Fixation System receive FDA 510(k) clearance?

SALVATION(R) External Fixation System received FDA 510(k) clearance on 2016-01-13, under 510(k) number K153635.

Who is the listed applicant for SALVATION(R) External Fixation System?

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

What is the FDA product code for SALVATION(R) External Fixation System?

The FDA product code for SALVATION(R) External Fixation System is KTT.

其他以 Wrightmedicaltechnologyinc 為申請人之記錄

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相關器械（代碼：KTT）

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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