510(k) K230794

Rebuilder Nerve Guidance Conduit by Celestray Biotech Company, LLC., — Product Code JXI

K230794 is an FDA 510(k) premarket notification submitted by Celestray Biotech Company, LLC., for the device "Rebuilder Nerve Guidance Conduit". The FDA issued a decision of Substantially Equivalent on January 29, 2024. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Celestray Biotech Company, LLC., has at least 1 other 510(k) clearance on record.