510(k) K253447

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) by Orthocon, Inc. — Product Code GXR

K253447 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)". The FDA issued a decision of Substantially Equivalent on March 16, 2026. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. Orthocon, Inc. has at least 10 other 510(k) clearances on record.