510(k) K230540

Patient Specific Planning Solution™ 3D Bone Models by Biomet Manufacturing Corp — Product Code LLZ

K230540 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "Patient Specific Planning Solution™ 3D Bone Models". The FDA issued a decision of Substantially Equivalent on July 25, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.