Cleared Traditional

K253363 - NeuroSpan Bridge

K253363 is an FDA 510(k) clearance for NeuroSpan Bridge, manufactured by Auxilium Biotechnologies, Inc.. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K253363 · Auxilium Biotechnologies, Inc. · Neurology device
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Jan 2026
Decision
109d
Days
Class 2
Risk

K253363 is an FDA 510(k) clearance for the NeuroSpan Bridge. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Auxilium Biotechnologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on January 17, 2026 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Auxilium Biotechnologies, Inc. devices

FDA 510(k) Submission Details - K253363

510(k) Number K253363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date January 17, 2026
Days to Decision 109 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 148d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXI Device Classification - Class 2, Special Controls

Product Code JXI Cuff, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXI Cuff, Nerve

All 26
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K253363.
SILKBridge
K260245 · KLISBio S.r.l. · Apr 2026
VersaCoat Nerve Protector (VTP-44G2)
K251505 · Alafair Biosciences · Jul 2025
VersaWrap Nerve Protector (VTP-2201)
K251175 · Alafair Biosciences · Jul 2025
Nerve Wrap (07-DW-001-TAB)
K242113 · Biocircuit Technologies, Inc. · Apr 2025
Remplir (ON-152, 15 x 20 mm)
K243889 · Orthocell, Ltd. · Apr 2025
Mochida Nerve Cuff
K233322 · Mochida Pharmaceutical Co., Ltd. · Jun 2024