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Cuff, Nerve

FDA product code JXI · 36 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5275
Review panel: NE
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1985-07-10 – 2026-04-09

JXI 2026-04-09

SILKBridge

Applicant KLISBio S.r.l.

K number K260245

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JXI 2026-01-17

NeuroSpan Bridge

Applicant Auxilium Biotechnologies, Inc.

K number K253363

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JXI 2025-07-22

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)

Applicant Alafair Biosciences

K number K251505

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JXI 2025-07-17

VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)

Applicant Alafair Biosciences

K number K251175

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JXI 2025-04-02

Remplir (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)

Applicant Orthocell, Ltd.

K number K243889

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JXI 2025-04-02

Nerve Wrap (07-DW-001-TAB)

Applicant Biocircuit Technologies, Inc.

K number K242113

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JXI 2024-06-21

Mochida Nerve Cuff

Applicant Mochida Pharmaceutical Co., Ltd.

K number K233322

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JXI 2024-02-12

NerveTape

Applicant Biocircuit Technologies, Inc.

K number K233533

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JXI 2024-01-29

Rebuilder Nerve Guidance Conduit

Applicant Celestray Biotech Company, LLC.,

K number K230794

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JXI 2023-11-02

VersaWrap Nerve Protector

Applicant Alafair Biosciences, Inc.

K number K232029

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JXI 2023-10-12

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)

Applicant Axogen Corporation

K number K231708

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JXI 2023-04-07

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)

Applicant Axogen Corporation

K number K223640

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JXI 2022-07-15

Nerve Tape

Applicant Biocircuit Technologies, Incorporated

K number K210665

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JXI 2022-02-10

NervAlign Nerve Cuff

Applicant Renerve, Ltd.

K number K202234

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JXI 2020-09-14

VersaWrap Nerve Protector

Applicant Alafair Biosciences, Inc.

K number K201631

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JXI 2019-05-31

NeuroShield

Applicant Monarch Bioimplants GmbH

K number K190246

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JXI 2018-04-24

Reaxon Plus

Applicant Medovent GmbH

K number K180222

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JXI 2017-08-08

AxoGen Nerve Cap

Applicant Axogen Corporation

K number K163446

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JXI 2017-06-01

Reinforced Flexible Collagen Nerve Cuff

Applicant Collagen Matrix, Inc.

K number K170656

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JXI 2017-01-06

NeuraGen 3D Nerve Guide Matrix

Applicant Integra LifeSciences Corporation

K number K163457

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JXI 2016-10-31

AxoGuard Nerve Connector

Applicant Cook Biotech Incorporated

K number K162741

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JXI 2016-06-22

NERBRIDGE

Applicant Toyobo Co., Ltd.

K number K152967

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JXI 2016-01-13

Nerve Capping Device

Applicant Polyganics Innovations BV

K number K152684

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JXI 2012-03-02

COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE

Applicant Biom'Up Sas

K number K103081

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JXI 2011-10-20

NEUROLAC(R) NERVE GUIDE

Applicant Polyganics B.V.,

K number K112267

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JXI 2010-08-05

SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331

Applicant Salumedica, LLC

K number K100382

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JXI 2006-07-14

COLLAGEN NERVE WRAP

Applicant Collagen Matrix, Inc.

K number K060952

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JXI 2005-05-04

NEUROLAC NERVE GUIDE

Applicant Polyganics B.V.,

K number K050573

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JXI 2004-07-16

NEURA WRAP NERVE PROTECTOR

Applicant Integra Lifesciences Corp.

K number K041620

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JXI 2003-10-10

NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

Applicant Polyganics B.V.,

K number K032115

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JXI 2003-05-15

SURGISIS NERVE CUFF

Applicant Cook Biotech, Inc.

K number K031069

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JXI 2001-09-21

COLLAGEN NERVE CUFF

Applicant Collagen Matrix, Inc.

K number K012814

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JXI 2001-06-22

NEUROGEN NERVE GUIDE

Applicant Integra Lifesciences Corp.

K number K011168

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JXI 2000-11-24

SALUMEDICA NERVE CUFF

Applicant Salumedica, LLC

K number K002098

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JXI 1999-03-22

NEUROTUBE

Applicant Neuroregen, LLC

K number K983007

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JXI 1985-07-10

FASTUBE NERVE REGENERATION DEVICE

Applicant Research Medical, Inc.

K number K850785

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