JDC · Class II · 21 CFR 888.3150

FDA Product Code JDC: Prosthesis, Elbow, Constrained, Cemented

Leading manufacturers include Zimmer, Inc., Biomet, Inc. and Depuy, Inc..

29
Total
29
Cleared
105d
Avg days
1986
Since

FDA 510(k) Cleared Prosthesis, Elbow, Constrained, Cemented Devices (Product Code JDC)

29 devices
1–24 of 29
Cleared Feb 16, 2019
TEMA Elbow System
K181362
Lima Corporate S.P.A.
Orthopedic · 269d
Cleared Jan 28, 2019
Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
K181307
Zimmer, Inc.
Orthopedic · 256d
Cleared Feb 03, 2016
Comprehensive SRS/Nexel Elbow
K153398
Biomet Manufacturing Corp
Orthopedic · 71d
Cleared Apr 23, 2015
Zimmer Nexel Total Elbow Ulnar Cement Diverter
K150501
Zimmer, Inc.
Orthopedic · 56d
Cleared Mar 12, 2013
ZIMMER NEXEL TOTAL ELBOW
K123862
Zimmer, Inc.
Orthopedic · 88d
Cleared Mar 25, 2009
DISCOVERY ELBOW - X-SMALL
K090473
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Apr 14, 2006
ACCLAIM TOTAL ELBOW SYSTEM
K060696
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Dec 09, 2005
COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
K053189
Zimmer, Inc.
Orthopedic · 24d
Cleared Sep 06, 2005
POROUS COATED DISCOVERY ELBOW
K051975
Biomet, Inc.
Orthopedic · 47d
Cleared Dec 08, 2004
LPS UPPER EXTREMITY
K042664
Depuy, Inc.
Orthopedic · 71d
Cleared May 17, 2004
COONRAD/MORREY ELBOW CEMENT RESTRICTOR
K040389
Zimmer, Inc.
Orthopedic · 90d
Cleared Dec 19, 2003
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
K033280
Biomet, Inc.
Orthopedic · 70d
Cleared Oct 10, 2001
DISCOVERY ELBOW
K013042
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Jan 12, 2001
BIOMET'S MINIMALLY CONSTRAINED ELBOW
K003253
Biomet, Inc.
Orthopedic · 87d
Cleared Oct 02, 2000
TORNIER TOTAL ELBOW PROSTHESIS
K000003
Tornier
Orthopedic · 273d
Cleared Jul 25, 2000
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
K001989
Zimmer, Inc.
Orthopedic · 26d
Cleared Jun 27, 2000
MODIFIED SINGLE AXLE TOTAL ELBOW
K000683
Biomet, Inc.
Orthopedic · 119d
Cleared Nov 05, 1999
DEPUY TOTAL ELBOW SYSTEM
K992656
DePuy Orthopaedics, Inc.
Orthopedic · 88d
Cleared Apr 30, 1999
SINGLE AXLE TOTAL ELBOW
K983036
Biomet, Inc.
Orthopedic · 242d
Cleared Aug 11, 1998
BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
K982398
Biomet, Inc.
Orthopedic · 32d
Cleared May 05, 1998
BIOMET BIAXIAL TOTAL ELBOW
K980428
Biomet, Inc.
Orthopedic · 90d
Cleared May 05, 1998
OSTEONICS TOTAL ELBOW SYSTEM
K980502
Osteonics Corp.
Orthopedic · 85d
Cleared Mar 02, 1998
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
K973357
Zimmer, Inc.
Orthopedic · 175d
Cleared Oct 09, 1990
PNEUMOTHORAX KIT, MODIFICATION
K904021
Arrow Intl., Inc.
Orthopedic · 41d

About Product Code JDC - Regulatory Context