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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 K253363
Device Name NeuroSpan Bridge
Applicant
Auxilium Biotechnologies, Inc.
333 Jackson Plz.
Ann Arbor,  MI  48103
Applicant Contact Jacob Koffler
Correspondent
Auxilium Biotechnologies, Inc.
333 Jackson Plz.
Ann Arbor,  MI  48103
Correspondent Contact Jacob Koffler
Regulation Number882.5275
Classification Product Code
JXI  
Date Received09/30/2025
Decision Date 01/17/2026
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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