510(k) K142814

Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial by Biomet Manufacturing, LLC — Product Code JDI

K142814 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing, LLC for the device "Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial". The FDA issued a decision of Substantially Equivalent on June 25, 2015. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Biomet Manufacturing, LLC has at least 10 other 510(k) clearances on record.