NeuroSpan Bridge— 510(k) K253363

Substantially Equivalent

Auxilium Biotechnologies, Inc.

FDA 510(k) clearance K253363 for NeuroSpan Bridge, Substantially Equivalent on 2026-01-17. Applicant: Auxilium Biotechnologies, Inc..

Clearance details

Applicant: Auxilium Biotechnologies, Inc.
Product code: Code JXI
Advisory panel: Neurology
Date received: 2025-09-30
Decision date: 2026-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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