FDA 510(k) Applications for Medical Device Product Code "OIY"
(Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive)

FDA 510(k) Number Applicant Device Name Decision Date
K100048 BIOMET MANUFACTURING CORP. E1 ANTIOXIDANT INFUSED TECHNOLOGY 03/09/2010
K101433 DEPUY ORTHOPAEDICS, INC. DEPUY ATTUNE KNEE SYSTEM 12/10/2010
K103756 DEPUY ORTHOPAEDICS, INC. DEPUY ATTUNE TOTAL KNEE SYSTEM 03/15/2011
K201347 DePuy Orthopaedics, Inc. DePuy ATTUNEÖáTotal Knee System 06/18/2020
K111433 DEPUY ORTHOPAEDICS, INC. DEPUY STTUNE (TM) PS KNEE SYSTEM 08/30/2011
K113756 ENCORE MEDICAL, L.P. HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA 03/14/2012
K103223 ENCORE MEDICAL, L.P. HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS 12/21/2010
K091956 ENCORE MEDICAL, L.P. HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 09/28/2010
K121727 ENCORE MEDICAL, L.P. MOVATION KNEE SYSTEM 08/15/2012
K120038 RENOVIS SURGICAL TECHNOLOGIES, LLC A200 KNEE SYSTEM 02/14/2013


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