FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K201631 |
Alafair Biosciences Inc |
VersaWrap Nerve Protector |
09/14/2020 |
K163446 |
AxoGen Corporation |
AxoGen Nerve Cap |
08/08/2017 |
K223640 |
AxoGen Corporation |
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) |
04/07/2023 |
K210665 |
BioCircuit Technologies, Incorporated |
Nerve Tape |
07/15/2022 |
K103081 |
BIOM'UP SAS |
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE |
03/02/2012 |
K012814 |
COLLAGEN MATRIX, INC. |
COLLAGEN NERVE CUFF |
09/21/2001 |
K060952 |
COLLAGEN MATRIX, INC. |
COLLAGEN NERVE WRAP |
07/14/2006 |
K131541 |
COLLAGEN MATRIX, INC. |
FLEXIBLE COOAGEN NERVE CUFF |
04/03/2014 |
K170656 |
Collagen Matrix, Inc. |
Reinforced Flexible Collagen Nerve Cuff |
06/01/2017 |
K162741 |
COOK BIOTECH INCORPORATED |
AxoGuard Nerve Connector |
10/31/2016 |
K132660 |
COOK BIOTECH INCORPORATED |
NERVE CUFF |
01/10/2014 |
K031069 |
COOK BIOTECH, INC. |
SURGISIS NERVE CUFF |
05/15/2003 |
K041620 |
INTEGRA LIFESCIENCES CORP. |
NEURA WRAP NERVE PROTECTOR |
07/16/2004 |
K011168 |
INTEGRA LIFESCIENCES CORP. |
NEUROGEN NERVE GUIDE |
06/22/2001 |
K130557 |
INTEGRA LIFESCIENCES CORPORATION |
NEURAGEN 3D |
04/24/2014 |
K163457 |
Integra LifeSciences Corporation |
NeuraGen 3D Nerve Guide Matrix |
01/06/2017 |
K143711 |
MEDOVENT GMBH |
Reaxon Plus |
12/02/2015 |
K180222 |
Medovent GmbH |
Reaxon Plus |
04/24/2018 |
K190246 |
Monarch Bioimplants GmbH |
NeuroShield |
05/31/2019 |
K983007 |
NEUROREGEN, L.L.C. |
NEUROTUBE |
03/22/1999 |
K050573 |
Polyganics BV |
NEUROLAC NERVE GUIDE |
05/04/2005 |
K032115 |
Polyganics BV |
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 |
10/10/2003 |
K112267 |
Polyganics BV |
NEUROLAC(R) NERVE GUIDE |
10/20/2011 |
K152684 |
POLYGANICS INNOVATIONS BV |
Nerve Capping Device |
01/13/2016 |
K202234 |
Renerve Ltd |
NervAlign Nerve Cuff |
02/10/2022 |
K002098 |
SALUMEDICA, L.L.C. |
SALUMEDICA NERVE CUFF |
11/24/2000 |
K100382 |
SALUMEDICA, L.L.C. |
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 |
08/05/2010 |
K152967 |
TOYOBO CO., LTD. |
NERBRIDGE |
06/22/2016 |