FDA 510(k) Applications for Medical Device Product Code "KWZ"
(Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K021661 |
BIOMET ORTHOPEDICS, INC. |
RINGLOC CONSTRAINED LINERS |
10/25/2002 |
K030047 |
BIOMET, INC. |
FREEDOM CONSTRAINED LINERS |
01/23/2003 |
K021728 |
BIOMET, INC. |
RINGLOC CONSTRAINED LINERS II |
10/25/2002 |
K030923 |
CENTERPULSE ORTHOPEDICS, INC. |
EPSILON DURASUL CONSTRAINED ACETABULAR LINER |
10/03/2003 |
K071059 |
DEPUY ORTHOPAEDICS, INC. |
DEPUY SPA POROUS COATED PROXIMAL SLEEVE |
11/09/2007 |
K071117 |
DEPUY ORTHOPAEDICS, INC. |
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS |
05/18/2007 |
K052079 |
DEPUY ORTHOPAEDICS, INC. |
PINNACLE CONSTRAINED ACETABULAR LINERS |
10/21/2005 |
K043058 |
DEPUY, INC. |
PINNACLE CONSTRAINED ACETABULAR LINERS |
03/14/2005 |
K023794 |
ENCORE MEDICAL, L.P. |
CONSTRAINED LINER |
04/01/2003 |
K161610 |
Encore Medical, L.P. |
EXPRT Revision Hip System |
11/09/2016 |
K163497 |
ENCORE MEDICAL, L.P. |
EXPRTÖ Revision Hip System - EXPRTÖ Hip Distal Stem, EXPRTÖ Hip Standard Offset Proximal Body Implant, EXPRTÖ Hip Lateral Offset Proximal Body Implant, EXPRTÖ Hip Capture Bolt |
03/02/2017 |
K040601 |
EXACTECH, INC. |
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS |
10/04/2004 |
K071676 |
EXACTECH, INC. |
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS |
07/19/2007 |
K063445 |
HOWMEDICA OSTEONICS CORP |
PCA CONSTRAINED ACETABULAR LINERS |
03/08/2007 |
K063552 |
HOWMEDICA OSTEONICS CORP |
SERIES II CONSTRAINED ACETABULAR LINERS |
03/08/2007 |
K063550 |
HOWMEDICA OSTEONICS CORP |
SYSTEM 12 CONSTRAINED ACETABULAR LINERS |
03/08/2007 |
K061654 |
HOWMEDICA OSTEONICS CORP |
TRIDENT CONSTRAINED ACETABULAR INSERT |
07/07/2006 |
K040225 |
OSTEOIMPLANT TECHNOLOGY, INC. |
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM |
05/06/2004 |
K083566 |
SMITH & NEPHEW, INC. |
R3 CONSTRAINED LINER, CONSTRAINED LINER |
03/03/2009 |
K021803 |
SMITH & NEPHEW, INC. |
REFLECTION CONSTRAINED LINER |
12/19/2002 |
K033442 |
SMITH & NEPHEW, INC. |
REFLECTION CONSTRAINED LINER |
11/26/2003 |
K122139 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW R3 CONSTRAINED LINERS |
10/16/2012 |
K111635 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW RJ CONSTRAINED LINERS |
09/09/2011 |
K162641 |
Smith & Nephew, Inc. |
Smith & Nephew, Inc. R3Ö Constrained Liner |
06/19/2017 |
K101730 |
ZIMMER, INC. |
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS |
12/03/2010 |
K072121 |
ZIMMER, INC. |
TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER |
01/07/2008 |
K021826 |
ZIMMER, INC. |
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES |
12/20/2002 |
K071718 |
ZIMMER, INC. |
TRILOGY LONGEVITY CONSTRAINED LINER |
07/13/2007 |
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