510(k) K230252

OFIX MIS App by Orthofix US, LLC — Product Code LLZ

K230252 is an FDA 510(k) premarket notification submitted by Orthofix US, LLC for the device "OFIX MIS App". The FDA issued a decision of Substantially Equivalent on Sep 26, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Orthofix US, LLC has at least 3 other 510(k) clearances on record.