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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