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 Medtronic Sofamor Danek USA, Inc..

54
Total
54
Cleared
106d
Avg days
1983
Since

FDA 510(k) Cleared Prosthesis, Hip, Cement Restrictor Devices (Product Code JDK)

54 devices
1–24 of 54
Cleared Apr 08, 2021
Mectaplug PE II
K210062
Medacta International S.A.
Orthopedic · 87d
Cleared Jul 12, 2006
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
K061698
Life Spine
Orthopedic · 26d
Cleared May 11, 2006
LIFE SPINE CEMENT RESTRICTOR
K060247
Life Spine
Orthopedic · 100d
Cleared Jul 22, 2004
PEEK CEMENT RESTRICTOR X-BOX
K041583
Innovasis, Inc.
Orthopedic · 41d
Cleared Jul 06, 2004
OPTIMESH 500E CEMENT RESTRICTOR
K033953
Spineology, Inc.
Orthopedic · 197d
Cleared Nov 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384
Implex Corp.
Orthopedic · 27d
Cleared Oct 07, 2003
NUVASIVE CEMENT RESTRICTOR
K032180
Nuvasive, Inc.
Orthopedic · 82d
Cleared Aug 08, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K032095
Interpore Cross Intl.
Orthopedic · 31d
Cleared May 16, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K023908
Interpore Cross Intl.
Orthopedic · 172d
Cleared Aug 16, 2002
CEMENT RESTRICTOR, SMALL AND LARGE
K021765
Exactech, Inc.
Orthopedic · 79d
Cleared Dec 05, 2001
CEMENT RESTRICTOR
K013663
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
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 Feb 28, 1997
OSTEONICS SCREW HOLE PLUGS
K965056
Osteonics Corp.
Orthopedic · 72d
Cleared Oct 30, 1992
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616
Osteonics Corp.
Orthopedic · 101d
Cleared Apr 08, 1991
OSTEONICS(R) MID-SHAFT CEMENT SPACER
K910461
Osteonics Corp.
Orthopedic · 63d
Cleared Mar 06, 1990
OSTEONICS CEMENT RESTRICTOR
K900462
Osteonics Corp.
Orthopedic · 34d
Cleared Oct 10, 1989
PT DISTAL TIP CEMENT SPACER
K894708
Osteonics Corp.
Orthopedic · 78d
Cleared Dec 29, 1987
OMNIFIT DISTAL STEM CEMENT SPACERS
K872528
Osteonics Corp.
Orthopedic · 187d
Cleared Sep 29, 1983
DOSIMETRY RELEASE OF RADIATION STERILIZ
K831512
Biomet, Inc.
Orthopedic · 140d

About Product Code JDK - Regulatory Context