510(k) K132697

ENCOMPASS 10/12 HIP STEM by Ortho Development Corp. — Product Code LPH

K132697 is an FDA 510(k) premarket notification submitted by Ortho Development Corp. for the device "ENCOMPASS 10/12 HIP STEM". The FDA issued a decision of Substantially Equivalent on June 20, 2014. 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. Ortho Development Corp. has at least 10 other 510(k) clearances on record.