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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Axogen Corporation. It received FDA 510(k) clearance on 2017-08-08 under 510(k) 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. The listed applicant is Axogen Corporation. The 510(k) number is K163446.

When did AxoGen Nerve Cap receive FDA 510(k) clearance?

AxoGen Nerve Cap received FDA 510(k) clearance on 2017-08-08, under 510(k) number K163446.

Who is the listed applicant for AxoGen Nerve Cap?

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

What is the FDA product code for AxoGen Nerve Cap?

The FDA product code for AxoGen Nerve Cap is JXI.

Related Clinical Trials

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.

NCT04865679Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve EndsACTIVE_NOT_RECRUITING

Other records listing Axogen Corporation as applicant

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.

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)

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

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

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