510(k) K151264

Restoration Anatomic Shell by Stryker Orthopaedics — Product Code LPH

K151264 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "Restoration Anatomic Shell". The FDA issued a decision of Substantially Equivalent on August 10, 2015. 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. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.