FDA 510(k)

醫康脊椎擴散系統

K 號：K161680 · 2017-03-24

決定日期2017-03-24

產品代碼GZT

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

MEDICON Spinal Spreading Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medicon EG. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K161680. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MEDICON Spinal Spreading Systems?

MEDICON Spinal Spreading Systems is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Medicon EG. The 510(k) number is K161680.

When did MEDICON Spinal Spreading Systems receive FDA 510(k) clearance?

MEDICON Spinal Spreading Systems received FDA 510(k) clearance on 2017-03-24, under 510(k) number K161680.

Who is the listed applicant for MEDICON Spinal Spreading Systems?

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

What is the FDA product code for MEDICON Spinal Spreading Systems?

The FDA product code for MEDICON Spinal Spreading Systems is GZT.

相關器械（代碼：GZT）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：GZT）

官方來源