510(k) K223640

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) by Axogen Corporation — Product Code JXI

K223640 is an FDA 510(k) premarket notification submitted by Axogen Corporation for the device "Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)". The FDA issued a decision of Substantially Equivalent on April 7, 2023. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Axogen Corporation has at least 2 other 510(k) clearances on record.