JDK · Class II · 21 CFR 878.3300

FDA Product Code JDK: Prosthesis, Hip, Cement Restrictor

Leading manufacturers include Osteonics Corp., Medtronic Sofamor Danek, Inc. and Spinal Concepts, Inc..

54
Total
54
Cleared
106d
Avg days
1983
Since
54 devices
25–48 of 54
Cleared Oct 29, 2002
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
K022615
Centerpulse Spine-Tech, Inc.
Orthopedic · 83d
Cleared Oct 04, 2002
NBD CEMENT RESTRICTOR DEVICE
K021788
New Business Development, LLC
Orthopedic · 126d
Cleared Aug 16, 2002
CEMENT RESTRICTOR, SMALL AND LARGE
K021765
Exactech, Inc.
Orthopedic · 79d
Cleared Aug 15, 2002
FORTITUDE CEMENT RESTRICTOR
K021719
Spinal Concepts, Inc.
Orthopedic · 84d
Cleared Aug 12, 2002
CADENCE CEMENT RESTRICTOR
K022218
Spinal Concepts, Inc.
Orthopedic · 34d
Cleared Jun 11, 2002
RABEA CEMENT RESTRICTOR
K020836
Signus Medical, LLC
Orthopedic · 89d
Cleared May 02, 2002
RPX TITANIUM CEMNT RESTRICTOR
K020344
Sulzer Spine-Tech
Orthopedic · 90d
Cleared Dec 05, 2001
CEMENT RESTRICTOR
K013663
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Oct 29, 2001
THEKEN LARGE CEMENT RESTRICTOR
K012462
Theken Surgical,Llc
Orthopedic · 89d
Cleared Oct 17, 2001
THEKEN SMALL CEMENT RESTRICTOR
K012278
Theken Surgical,Llc
Orthopedic · 90d
Cleared Oct 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 229d
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Aug 03, 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
Cleared Aug 01, 2001
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255
Medtronic Sofamor Danek, Inc.
Orthopedic · 14d
Cleared Jul 26, 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Feb 14, 2001
TITANIUM CEMENT RESTRICTOR (TCR)
K003718
Medtronic Sofamor Danek, Inc.
Orthopedic · 72d
Cleared Jul 30, 1999
RABEA DEVICE, MODEL PXXXXXX
K990345
Signus Medizintechnik GmbH
Orthopedic · 176d
Cleared Feb 28, 1997
OSTEONICS SCREW HOLE PLUGS
K965056
Osteonics Corp.
Orthopedic · 72d
Cleared Mar 22, 1994
BONE CEMENT RESTRICTOR
K926216
Biodynamic Technologies, Inc.
Orthopedic · 467d
Cleared Oct 30, 1992
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616
Osteonics Corp.
Orthopedic · 101d
Cleared Jun 28, 1991
LIMA CEMENT RESTRICTOR
K911338
Turnkey Intergration USA, Inc.
Orthopedic · 94d
Cleared Apr 08, 1991
OSTEONICS(R) MID-SHAFT CEMENT SPACER
K910461
Osteonics Corp.
Orthopedic · 63d
Cleared Nov 20, 1990
S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
K904746
Joint Medical Products Corp.
Orthopedic · 33d
Cleared Mar 06, 1990
OSTEONICS CEMENT RESTRICTOR
K900462
Osteonics Corp.
Orthopedic · 34d