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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K231708
Device Name 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
13631 Progress Blvd., Suite 400
Alachua,  FL  32615
Applicant Contact Shravani Shastry
Correspondent
Axogen Corporation
13631 Progress Blvd., Suite 400
Alachua,  FL  32615
Correspondent Contact Shravani Shastry
Regulation Number882.5275
Classification Product Code
JXI  
Date Received06/12/2023
Decision Date 10/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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