Axoguard HA+ Nerve Protector (5 models)— 510(k) K223640

Name: FDA 510(k) clearance K223640
Creator: U.S. Food and Drug Administration
Published: 2023-04-07

Substantially Equivalent

Axogen Corporation

FDA 510(k) clearance K223640 for Axoguard HA+ Nerve Protector (5 models), Substantially Equivalent on 2023-04-07. Applicant: Axogen Corporation. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Axogen Corporation
Product code: Code JXI
Device class: Class 2
Regulation: 21 CFR 882.5275
Advisory panel: Neurology
Date received: 2022-12-05
Decision date: 2023-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXI

view all

K260245 — SILKBridge2026-04-09
K253363 — NeuroSpan Bridge2026-01-17
K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)2025-07-22
K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)2025-07-17
K242113 — Nerve Wrap (07-DW-001-TAB)2025-04-02

More clearances from Axogen Corporation

view all

K231708 — Axoguard HA+ Nerve Protector (5 models)2023-10-12
K163446 — AxoGen Nerve Cap2017-08-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.