FDA 510(k)

Durepair Dura再生基质

K号: K161370 · 2016-11-02

决定日期2016-11-02

产品代码GXQ

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决定实质等同

器械摘要

Durepair Dura Regeneration Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2016-11-02 under 510(k) number K161370. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Durepair Dura Regeneration Matrix?

Durepair Dura Regeneration Matrix is a medical device that received FDA 510(k) clearance on 2016-11-02. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K161370.

When did Durepair Dura Regeneration Matrix receive FDA 510(k) clearance?

Durepair Dura Regeneration Matrix received FDA 510(k) clearance on 2016-11-02, under 510(k) number K161370.

Who is the listed applicant for Durepair Dura Regeneration Matrix?

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

What is the FDA product code for Durepair Dura Regeneration Matrix?

The FDA product code for Durepair Dura Regeneration Matrix is GXQ.

列明Medtronic Neurosurgery为申报人的其他记录

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