510(k) K220483

Platform® Acetabular System by Total Joint Orthopedics, Inc. — Product Code LZO

K220483 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "Platform® Acetabular System". The FDA issued a decision of Substantially Equivalent on September 23, 2022. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Total Joint Orthopedics, Inc. has at least 10 other 510(k) clearances on record.