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. 2018 Dec 13;169(9):240–251. doi: 10.1007/s10354-018-0675-6

Table 1.

FDA-approved nerve tubes for peripheral nerve repair. (Modified and supplemented from FDA Medical Device Database [104])

Name Product name Company Date of approval K510 Available Length (cm) Material
Neuragen 3D NeuraGen® Integra Lifescience Corporation, Plainsboro, NJ, USA Apr 24, 2014 K130557 3.0 Collagen
Neurogen Nerve Guide NeuroGen® Integra Lifescience Corporation, Plainsboro, NJ, USA Jun 22, 2001 K011168 3.0 Collagen
Flexible collagen nerve NeuroFlex® Collagen Matrix Inc., Oakland, NJ, USA Apr 03, 2014 K131541 2.5 Collagen
Collagen nerve cuff NeuroMatrix® Collagen Matrix Inc., Oakland, NJ, USA Sep 21, 2001 K012814 n.a Collagen
Reaxon Plus® Reaxon Plus® Medovent GmbH, Mainz, Germany Dec 02, 2015 K143711 1.0 Chitosan
Neurotube® Neurotube® Neuroregen L.C.C, Bel Air, MD, USA Mar 22, 1999 K983007 3.0 Poly(DL-lactide-ε-caprolactone)
Neurolac® Nerve Guide Neurolac® Polyganics BV, Rozenburglaan, Netherlands Oct 20, 2011 K112267 2.0 Poly(DL-lactide-ε-caprolactone)
Neurolac® Nerve Guide Neurolac® Polyganics BV, Rozenburglaan, Netherlands May 04, 2005 K050573 2.0 Poly(DL-lactide-ε-caprolactone)
Neurolac® Nerve Guide Models NG01-15/03, NG01-020/03, NG01-025/03, NG01-030/03 Neurolac® Polyganics BV, Rozenburglaan, Netherlands Oct 10, 2003 K032115 2.0 Poly(DL-lactide-ε-caprolactone)
AxoGen Avance® AxoGen Avance® AxoGen, Alachua, FL, USA 5.0 Human nerve allograft