JXI · Class II · 21 CFR 882.5275

FDA Product Code JXI: Cuff, Nerve

Leading manufacturers include Collagen Matrix, Inc., Polyganics B.V., and Axogen Corporation.

40
Total
40
Cleared
167d
Avg days
1985
Since
40 devices
25–40 of 40
Cleared Apr 24, 2014
NEURAGEN 3D
K130557
Integra LifeSciences Corporation
Neurology · 416d
Cleared Apr 03, 2014
FLEXIBLE COOAGEN NERVE CUFF
K131541
Collagen Matrix, Inc.
Neurology · 309d
Cleared Jan 10, 2014
NERVE CUFF
K132660
Cook Biotech Incorporated
Neurology · 137d
Cleared Mar 02, 2012
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
K103081
Biom'Up Sas
Neurology · 500d
Cleared Oct 20, 2011
NEUROLAC(R) NERVE GUIDE
K112267
Polyganics B.V.,
Neurology · 73d
Cleared Aug 05, 2010
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
K100382
Salumedica, LLC
Neurology · 170d
Cleared Jul 14, 2006
COLLAGEN NERVE WRAP
K060952
Collagen Matrix, Inc.
Neurology · 99d
Cleared May 04, 2005
NEUROLAC NERVE GUIDE
K050573
Polyganics B.V.,
Neurology · 58d
Cleared Jul 16, 2004
NEURA WRAP NERVE PROTECTOR
K041620
Integra Lifesciences Corp.
Neurology · 30d
Cleared Oct 10, 2003
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
K032115
Polyganics B.V.,
Neurology · 93d
Cleared May 15, 2003
SURGISIS NERVE CUFF
K031069
Cook Biotech, Inc.
Neurology · 41d
Cleared Sep 21, 2001
COLLAGEN NERVE CUFF
K012814
Collagen Matrix, Inc.
Neurology · 30d
Cleared Jun 22, 2001
NEUROGEN NERVE GUIDE
K011168
Integra Lifesciences Corp.
Neurology · 66d
Cleared Nov 24, 2000
SALUMEDICA NERVE CUFF
K002098
Salumedica, LLC
Neurology · 136d
Cleared Mar 22, 1999
NEUROTUBE
K983007
Neuroregen, LLC
Neurology · 206d
Cleared Jul 10, 1985
FASTUBE NERVE REGENERATION DEVICE
K850785
Research Medical, Inc.
Neurology · 134d