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FDA 510(k)

NeuroShield

K-Number: K190246 · 2019-05-31

ApplicantMonarch Bioimplants GmbH
Decision Date2019-05-31
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroShield is a medical device manufactured by Monarch Bioimplants GmbH. It received FDA 510(k) clearance on 2019-05-31 under approval number K190246. 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 NeuroShield?

NeuroShield is a medical device that received FDA 510(k) clearance on 2019-05-31. It is manufactured by Monarch Bioimplants GmbH. The 510(k) number is K190246.

When was NeuroShield approved by the FDA?

NeuroShield received FDA 510(k) clearance on 2019-05-31, under approval number K190246.

What company makes NeuroShield?

NeuroShield is manufactured by Monarch Bioimplants GmbH.

What is the FDA product code for NeuroShield?

The FDA product code for NeuroShield is JXI.

Related Devices (Code: JXI)

K162741AxoGuard Nerve ConnectorCook Biotech Incorporated K152967NERBRIDGEToyobo Co., Ltd. K152684Nerve Capping DevicePolyganics Innovations BV K163446AxoGen Nerve CapAxogen Corporation K170656Reinforced Flexible Collagen Nerve CuffCollagen Matrix, Inc. K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation

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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