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)— 510(k) K231708

Substantially Equivalent

Axogen Corporation

FDA 510(k) clearance K231708 for 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), Substantially Equivalent on 2023-10-12. Applicant: Axogen Corporation.

Clearance details

Applicant: Axogen Corporation
Product code: Code JXI
Advisory panel: Neurology
Date received: 2023-06-12
Decision date: 2023-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, US

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