ClearanceBrief
Panels › Orthopedic › Product code JDC · Class 2

Prosthesis, Elbow, Constrained, Cemented

Regulation 888.3150

0510(k)s in 12 months (29 all time)
1recalls in 12 months (21 all time)
20recalls that name a 510(k)
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Top companies in JDC

Decided510(k)Device and applicantCode
Feb 16, 2019K181362TEMA Elbow System
Lima Corporate S.P.A., IT
JDC
Jan 28, 2019K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
Zimmer, Inc.
JDC
Feb 3, 2016K153398Comprehensive SRS/Nexel Elbow
Biomet Manufacturing Corp
JDC
Apr 23, 2015K150501Zimmer Nexel Total Elbow Ulnar Cement Diverter
Zimmer, Inc.
JDC
Mar 12, 2013K123862ZIMMER NEXEL TOTAL ELBOW
Zimmer, Inc.
JDC
Mar 25, 2009K090473DISCOVERY ELBOW - X-SMALL
Biomet Manufacturing Corp
JDC
Apr 14, 2006K060696ACCLAIM TOTAL ELBOW SYSTEM
DePuy Orthopaedics, Inc.
JDC
Dec 9, 2005K053189COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
Zimmer, Inc.
JDC
Sep 6, 2005K051975POROUS COATED DISCOVERY ELBOW
Biomet, Inc.
JDC
Dec 8, 2004K042664LPS UPPER EXTREMITY
Depuy, Inc.
JDC
May 17, 2004K040389COONRAD/MORREY ELBOW CEMENT RESTRICTOR
Zimmer, Inc.
JDC
Dec 19, 2003K033280DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
Biomet, Inc.
JDC
Oct 10, 2001K013042DISCOVERY ELBOW
Biomet Orthopedics, Inc.
JDC
Jan 12, 2001K003253BIOMET'S MINIMALLY CONSTRAINED ELBOW
Biomet, Inc.
JDC
Oct 2, 2000K000003TORNIER TOTAL ELBOW PROSTHESIS
Tornier
JDC
Jul 25, 2000K001989COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
Zimmer, Inc.
JDC
Jun 27, 2000K000683MODIFIED SINGLE AXLE TOTAL ELBOW
Biomet, Inc.
JDC
Nov 5, 1999K992656DEPUY TOTAL ELBOW SYSTEM
DePuy Orthopaedics, Inc.
JDC
Apr 30, 1999K983036SINGLE AXLE TOTAL ELBOW
Biomet, Inc.
JDC
Aug 11, 1998K982398BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
Biomet, Inc.
JDC
May 5, 1998K980502OSTEONICS TOTAL ELBOW SYSTEM
Osteonics Corp.
JDC
May 5, 1998K980428BIOMET BIAXIAL TOTAL ELBOW
Biomet, Inc.
JDC
Mar 2, 1998K973357COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
Zimmer, Inc.
JDC
Aug 8, 1996K955916TOWNLEY TOTAL ELBOW SYSTEM
Biologically Oriented Prostheses
JDC
Oct 22, 1990K901581GSB ELBOW
Allo Pro Corp.
JDC
Oct 9, 1990K904021PNEUMOTHORAX KIT, MODIFICATION
Arrow Intl., Inc.
JDC
Feb 3, 1989K883665COONRAD III TOTAL ELBOW
Zimmer, Inc.
JDC
Jun 25, 1987K872084POROCOAT MARK II TOTAL ELBOW
Depuy, Inc.
JDC
Jun 27, 1986K861680OSTEONICS ELBOW PROSTHESIS
Osteonics Corp.
JDC

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