FDA 510(k)

ACRON™ TLIF 系統

K 號：K171151 · 2018-04-27

決定日期2018-04-27

產品代碼MAX

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器材摘要

ACRON™ TLIF System is the device name listed in this FDA 510(k) record. The listed applicant is Spinemed Ges.M.B.H. It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K171151. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACRON™ TLIF System?

ACRON™ TLIF System is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is Spinemed Ges.M.B.H. The 510(k) number is K171151.

When did ACRON™ TLIF System receive FDA 510(k) clearance?

ACRON™ TLIF System received FDA 510(k) clearance on 2018-04-27, under 510(k) number K171151.

Who is the listed applicant for ACRON™ TLIF System?

The FDA 510(k) record lists Spinemed Ges.M.B.H as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACRON™ TLIF System?

The FDA product code for ACRON™ TLIF System is MAX.

相關器械（代碼：MAX）

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器材摘要

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相關器械（代碼：MAX）

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