510(k) K191906

MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF by MiRus, LLC — Product Code MAX

K191906 is an FDA 510(k) premarket notification submitted by MiRus, LLC for the device "MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF". The FDA issued a decision of Substantially Equivalent on May 18, 2020. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. MiRus, LLC has at least 10 other 510(k) clearances on record.