510(k) K192071

iNSitu Total Hip System by Theken Companies, LLC — Product Code LPH

K192071 is an FDA 510(k) premarket notification submitted by Theken Companies, LLC for the device "iNSitu Total Hip System". The FDA issued a decision of Substantially Equivalent on August 30, 2019. 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, LLC has at least 4 other 510(k) clearances on record.