510(k) K142814

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2015
Date Received
September 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type