FDA 510(k) Applications for Medical Device Product Code "JDC"
(Prosthesis, Elbow, Constrained, Cemented)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K955916 |
BIOLOGICALLY ORIENTED PROSTHESES |
TOWNLEY TOTAL ELBOW SYSTEM |
08/08/1996 |
K153398 |
BIOMET MANUFACTURING CORP. |
Comprehensive SRS/Nexel Elbow |
02/03/2016 |
K090473 |
BIOMET MANUFACTURING CORP. |
DISCOVERY ELBOW - X-SMALL |
03/25/2009 |
K013042 |
BIOMET ORTHOPEDICS, INC. |
DISCOVERY ELBOW |
10/10/2001 |
K982398 |
BIOMET, INC. |
BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW |
08/11/1998 |
K980428 |
BIOMET, INC. |
BIOMET BIAXIAL TOTAL ELBOW |
05/05/1998 |
K003253 |
BIOMET, INC. |
BIOMET'S MINIMALLY CONSTRAINED ELBOW |
01/12/2001 |
K033280 |
BIOMET, INC. |
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM |
12/19/2003 |
K000683 |
BIOMET, INC. |
MODIFIED SINGLE AXLE TOTAL ELBOW |
06/27/2000 |
K051975 |
BIOMET, INC. |
POROUS COATED DISCOVERY ELBOW |
09/06/2005 |
K983036 |
BIOMET, INC. |
SINGLE AXLE TOTAL ELBOW |
04/30/1999 |
K060696 |
DEPUY ORTHOPAEDICS, INC. |
ACCLAIM TOTAL ELBOW SYSTEM |
04/14/2006 |
K992656 |
DEPUY ORTHOPAEDICS, INC. |
DEPUY TOTAL ELBOW SYSTEM |
11/05/1999 |
K042664 |
DEPUY, INC. |
LPS UPPER EXTREMITY |
12/08/2004 |
K181362 |
Limacorporate S.p.A. |
TEMA Elbow System |
02/16/2019 |
K980502 |
OSTEONICS CORP. |
OSTEONICS TOTAL ELBOW SYSTEM |
05/05/1998 |
K000003 |
TORNIER |
TORNIER TOTAL ELBOW PROSTHESIS |
10/02/2000 |
K181307 |
Zimmer Inc |
Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow |
01/28/2019 |
K040389 |
ZIMMER, INC. |
COONRAD/MORREY ELBOW CEMENT RESTRICTOR |
05/17/2004 |
K053189 |
ZIMMER, INC. |
COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES |
12/09/2005 |
K973357 |
ZIMMER, INC. |
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN |
03/02/1998 |
K001989 |
ZIMMER, INC. |
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES |
07/25/2000 |
K123862 |
ZIMMER, INC. |
ZIMMER NEXEL TOTAL ELBOW |
03/12/2013 |
K150501 |
ZIMMER, INC. |
Zimmer Nexel Total Elbow Ulnar Cement Diverter |
04/23/2015 |
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