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JXI — Cuff, Nerve Class II

FDA Device Classification

Classification Details

Product Code
JXI
Device Class
Class II
Regulation Number
882.5275
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253363auxilium biotechnologiesNeuroSpan BridgeJanuary 17, 2026
K251505alafair biosciencesVersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)July 22, 2025
K251175alafair biosciencesVersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)July 17, 2025
K243889orthocellRemplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 April 2, 2025
K242113biocircuit technologiesNerve Wrap (07-DW-001-TAB)April 2, 2025
K233322mochida pharmaceutical coMochida Nerve CuffJune 21, 2024
K233533biocircuit technologiesNerveTapeFebruary 12, 2024
K230794celestray biotech company, llcRebuilder Nerve Guidance ConduitJanuary 29, 2024
K232029alafair biosciencesVersaWrap Nerve ProtectorNovember 2, 2023
K231708axogen corporationAxoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); AxOctober 12, 2023
K223640axogen corporationAxoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); AxApril 7, 2023
K210665biocircuit technologies, incorporatedNerve TapeJuly 15, 2022
K202234renerveNervAlign Nerve CuffFebruary 10, 2022
K201631alafair biosciencesVersaWrap Nerve ProtectorSeptember 14, 2020
K190246monarch bioimplantsNeuroShieldMay 31, 2019
K180222medoventReaxon PlusApril 24, 2018
K163446axogen corporationAxoGen Nerve CapAugust 8, 2017
K170656collagen matrixReinforced Flexible Collagen Nerve CuffJune 1, 2017
K163457integra lifesciences corporationNeuraGen 3D Nerve Guide MatrixJanuary 6, 2017
K162741cook biotech incorporatedAxoGuard Nerve ConnectorOctober 31, 2016