Axogen Corporation is one of 16099 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Axogen Corporation - FDA 510(k) Cleared Devices
Recent clearances: Axoguard HA+ Nerve Protector (AGHA12), Axoguard HA+ Nerve Protector (AGHA12), AxoGen Nerve Cap
3
Total
3
Cleared
0
Denied
Axogen Corporation has 3 FDA 510(k) cleared medical devices. Based in Alachua, US.
Last cleared in 2023. Active since 2017. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Axogen Corporation Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by New South Regulatory, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Axogen Corporation
3 devices