510(k) K170656

Reinforced Flexible Collagen Nerve Cuff by Collagen Matrix, Inc. — Product Code JXI

K170656 is an FDA 510(k) premarket notification submitted by Collagen Matrix, Inc. for the device "Reinforced Flexible Collagen Nerve Cuff". The FDA issued a decision of Substantially Equivalent on June 1, 2017. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Collagen Matrix, Inc. has at least 10 other 510(k) clearances on record.