510(k) K210035

ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System by Aegis Spine — Product Code OUR

K210035 is an FDA 510(k) premarket notification submitted by Aegis Spine for the device "ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System". The FDA issued a decision of Substantially Equivalent on Feb 16, 2021. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Aegis Spine has 5 other 510(k) clearances on record.