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 a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2017-01-06 under approval 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. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K163457.
When was NeuraGen 3D Nerve Guide Matrix approved by the FDA?
NeuraGen 3D Nerve Guide Matrix received FDA 510(k) clearance on 2017-01-06, under approval number K163457.
What company makes NeuraGen 3D Nerve Guide Matrix?
NeuraGen 3D Nerve Guide Matrix is manufactured by Integra LifeSciences Corporation.
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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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.