510(k) K253363

Device
NeuroSpan Bridge
Applicant
Auxilium Biotechnologies, Inc.
510(k) number
K253363
Product code
JXI
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-17
Date received
2025-09-30
Regulation
882.5275
Classification name
Cuff, Nerve
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jacob Koffler
Address
333 Jackson Plz. Ann Arbor MI US 48103 48103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JXI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260245SILKBridgeKLISBio S.r.l.2026-04-09
K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair Biosciences2025-07-22
K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair Biosciences2025-07-17
K243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.2025-04-02
K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.2025-04-02
K233322Mochida Nerve CuffMochida Pharmaceutical Co., Ltd.2024-06-21
K233533NerveTapeBiocircuit Technologies, Inc.2024-02-12
K230794Rebuilder Nerve Guidance ConduitCelestray Biotech Company, LLC.,2024-01-29
K232029VersaWrap Nerve ProtectorAlafair Biosciences, Inc.2023-11-02
K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)Axogen Corporation2023-10-12
K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)Axogen Corporation2023-04-07
K210665Nerve TapeBiocircuit Technologies, Incorporated2022-07-15
K202234NervAlign Nerve CuffRenerve, Ltd.2022-02-10
K201631VersaWrap Nerve ProtectorAlafair Biosciences, Inc.2020-09-14
K190246NeuroShieldMonarch Bioimplants GmbH2019-05-31