JXI · Class II · 21 CFR 882.5275

FDA Product Code JXI: Cuff, Nerve

Leading manufacturers include Alafair Biosciences, Inc., Axogen Corporation and Biocircuit Technologies, Inc..

40
Total
40
Cleared
167d
Avg days
1985
Since
Stable submission activity - 6 submissions in the last 2 years
Review times improving: avg 117d recently vs 176d historically

FDA 510(k) Cleared Cuff, Nerve Devices (Product Code JXI)

40 devices
1–24 of 40
Cleared Apr 09, 2026
SILKBridge
K260245
KLISBio S.r.l.
Neurology · 72d
Cleared Jan 17, 2026
NeuroSpan Bridge
K253363
Auxilium Biotechnologies, Inc.
Neurology · 109d
Cleared Jul 22, 2025
VersaCoat Nerve Protector (VTP-44G2)
K251505
Alafair Biosciences
Neurology · 67d
Cleared Jul 17, 2025
VersaWrap Nerve Protector (VTP-2201)
K251175
Alafair Biosciences
Neurology · 92d
Cleared Apr 02, 2025
Nerve Wrap (07-DW-001-TAB)
K242113
Biocircuit Technologies, Inc.
Neurology · 257d
Cleared Apr 02, 2025
Remplir (ON-152, 15 x 20 mm)
K243889
Orthocell, Ltd.
Neurology · 105d
Cleared Jun 21, 2024
Mochida Nerve Cuff
K233322
Mochida Pharmaceutical Co., Ltd.
Neurology · 266d
Cleared Feb 12, 2024
NerveTape
K233533
Biocircuit Technologies, Inc.
Neurology · 102d
Cleared Jan 29, 2024
Rebuilder Nerve Guidance Conduit
K230794
Celestray Biotech Company, LLC.,
Neurology · 313d
Cleared Nov 02, 2023
VersaWrap Nerve Protector
K232029
Alafair Biosciences, Inc.
Neurology · 118d
Cleared Oct 12, 2023
Axoguard HA+ Nerve Protector (AGHA12)
K231708
Axogen Corporation
Neurology · 122d
Cleared Apr 07, 2023
Axoguard HA+ Nerve Protector (AGHA12)
K223640
Axogen Corporation
Neurology · 123d
Cleared Jul 15, 2022
Nerve Tape
K210665
Biocircuit Technologies, Incorporated
Neurology · 497d
Cleared Feb 10, 2022
NervAlign Nerve Cuff
K202234
Renerve, Ltd.
Neurology · 552d
Cleared Sep 14, 2020
VersaWrap Nerve Protector
K201631
Alafair Biosciences, Inc.
Neurology · 90d
Cleared May 31, 2019
NeuroShield
K190246
Monarch Bioimplants GmbH
Neurology · 114d
Cleared Apr 24, 2018
Reaxon Plus
K180222
Medovent GmbH
Neurology · 89d

About Product Code JXI - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code JXI since 1985, with 40 receiving FDA clearance (average review time: 167 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - JXI Product Code

Recent submissions under JXI have taken an average of 117 days to reach a decision - down from 176 days historically, suggesting improved FDA processing for this classification.

JXI devices are reviewed by the Neurology panel. Browse all Neurology devices →