510(k) K243889

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) by Orthocell, Ltd. — Product Code JXI

K243889 is an FDA 510(k) premarket notification submitted by Orthocell, Ltd. for the device "Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)". The FDA issued a decision of Substantially Equivalent on April 2, 2025. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Orthocell, Ltd. has at least 1 other 510(k) clearance on record.