AxoGen Nerve Cap
K-Number: K163446 · 2017-08-08
ApplicantAxogen Corporation
Decision Date2017-08-08
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
AxoGen Nerve Cap is a medical device manufactured by Axogen Corporation. It received FDA 510(k) clearance on 2017-08-08 under approval number K163446. 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 AxoGen Nerve Cap?
AxoGen Nerve Cap is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by Axogen Corporation. The 510(k) number is K163446.
When was AxoGen Nerve Cap approved by the FDA?
AxoGen Nerve Cap received FDA 510(k) clearance on 2017-08-08, under approval number K163446.
What company makes AxoGen Nerve Cap?
AxoGen Nerve Cap is manufactured by Axogen Corporation.
What is the FDA product code for AxoGen Nerve Cap?
The FDA product code for AxoGen Nerve Cap is JXI.
Other Devices by Axogen Corporation
K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
Related Devices (Code: JXI)
K162741AxoGuard Nerve ConnectorCook Biotech Incorporated
K152967NERBRIDGEToyobo Co., Ltd.
K152684Nerve Capping DevicePolyganics Innovations BV
K170656Reinforced Flexible Collagen Nerve CuffCollagen Matrix, Inc.
K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation
K180222Reaxon PlusMedovent GmbH
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.