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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