510(k) K213580

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length by Total Joint Othopedics, Inc. — Product Code LZO

K213580 is an FDA 510(k) premarket notification submitted by Total Joint Othopedics, Inc. for the device "Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length". The FDA issued a decision of Substantially Equivalent on Dec 3, 2021. 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 Othopedics, Inc. has at least 7 other 510(k) clearances on record.