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

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 Oct 05, 2006
KMI CEMENT RESTRICTOR IMPLANT
K061465
Kinetikos Medical, Inc.
Orthopedic · 132d
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 Mar 16, 2006
SPINAL USA CEMENT RESTRICTOR SYSTEM
K060132
Spinal USA
Orthopedic · 57d
Cleared Dec 06, 2005
INTERBODY INNOVATIONS CEMENT RESTRICTOR
K051371
Interbody Innovations, Llp
Orthopedic · 194d
Cleared Nov 21, 2005
SKELITE RESORBABLE CEMENT RESTRICTOR
K051836
Millenium Biologix, Inc.
Orthopedic · 138d
Cleared Oct 07, 2005
NOVASPINE CEMENT RESTRICTOR NSCR
K051607
Novaspine, LLC
Orthopedic · 112d
Cleared Oct 05, 2005
SCIENT'X CEMENT RESTRICTOR
K052367
Scient'X
Orthopedic · 37d
Cleared Jun 17, 2005
POLYGRAFT BGS
K041382
Osteobiologics, Inc.
Orthopedic · 388d
Cleared Apr 15, 2005
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
K050699
Amedica Corp.
Orthopedic · 28d
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 22, 2003
TRAXIS CEMENT RESTRICTOR
K031318
Spinal Concepts, Inc.
Orthopedic · 119d
Cleared Aug 08, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K032095
Interpore Cross Intl.
Orthopedic · 31d
Cleared Jul 24, 2003
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
K031837
Spinal Concepts, Inc.
Orthopedic · 38d
Cleared Jun 12, 2003
OTI BONE CEMENT PLUG
K030608
Osteoimplant Technology, Inc.
Orthopedic · 106d
Cleared May 16, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K023908
Interpore Cross Intl.
Orthopedic · 172d
Cleared Nov 27, 2002
CADENCE PEEK CEMEENT RESTRICTOR
K023647
Spinal Concepts, Inc.
Orthopedic · 28d
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

About Product Code JDK - Regulatory Context