510(k) K190276

Provident II Hip Stem by Stelkast, Inc. — Product Code LPH

K190276 is an FDA 510(k) premarket notification submitted by Stelkast, Inc. for the device "Provident II Hip Stem". The FDA issued a decision of Substantially Equivalent on March 8, 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. Stelkast, Inc. has at least 10 other 510(k) clearances on record.