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FDA 510(k)

NeuraGen 3D Nerve Guide Matrix

K-Number: K163457 · 2017-01-06

ApplicantIntegra LifeSciences Corporation
Decision Date2017-01-06
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuraGen 3D Nerve Guide Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K163457. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuraGen 3D Nerve Guide Matrix?

NeuraGen 3D Nerve Guide Matrix is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K163457.

When did NeuraGen 3D Nerve Guide Matrix receive FDA 510(k) clearance?

NeuraGen 3D Nerve Guide Matrix received FDA 510(k) clearance on 2017-01-06, under 510(k) number K163457.

Who is the listed applicant for NeuraGen 3D Nerve Guide Matrix?

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

What is the FDA product code for NeuraGen 3D Nerve Guide Matrix?

The FDA product code for NeuraGen 3D Nerve Guide Matrix is JXI.

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Related Devices (Code: JXI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260245SILKBridgeKLISBio S.r.l.K253363NeuroSpan BridgeAuxilium Biotechnologies, Inc.K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair BiosciencesK251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair BiosciencesK243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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