510(k) K220336

Mg-PSZ Ceramic Femoral Head by Theken Companies — Product Code LPH

K220336 is an FDA 510(k) premarket notification submitted by Theken Companies for the device "Mg-PSZ Ceramic Femoral Head". The FDA issued a decision of Substantially Equivalent on September 30, 2022. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Theken Companies has at least 4 other 510(k) clearances on record.