FDA 510(k) Applications for Medical Device Product Code "JDK"
(Prosthesis, Hip, Cement Restrictor)

FDA 510(k) Number Applicant Device Name Decision Date
K050699 AMEDICA CORP. MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 04/15/2005
K022615 CENTERPULSE SPINE-TECH, INC. CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR 10/29/2002
K021765 EXACTECH, INC. CEMENT RESTRICTOR, SMALL AND LARGE 08/16/2002
K033384 IMPLEX CORP. THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ 11/19/2003
K041583 INNOVASIS, INC. PEEK CEMENT RESTRICTOR X-BOX 07/22/2004
K051371 INTERBODY INNOVATIONS LLP INTERBODY INNOVATIONS CEMENT RESTRICTOR 12/06/2005
K023908 INTERPORE CROSS INTL. INTERPORE CROSS CEMENT RESTRICTOR 05/16/2003
K032095 INTERPORE CROSS INTL. INTERPORE CROSS CEMENT RESTRICTOR 08/08/2003
K061465 KINETIKOS MEDICAL, INC. KMI CEMENT RESTRICTOR IMPLANT 10/05/2006
K060247 LIFE SPINE LIFE SPINE CEMENT RESTRICTOR 05/11/2006
K061698 LIFE SPINE MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR 07/12/2006
K210062 Medacta International SA Mectaplug PE II 04/08/2021
K011443 MEDTRONIC SOFAMOR DANEK USA, INC. THREADED CEMENT RESTRICTOR (CR) TITANIUM 08/03/2001
K010528 MEDTRONIC SOFAMOR DANEK USA, INC. TITANIUM CEMENT RESTRICTOR MATERIAL PEEK 10/10/2001
K013014 MEDTRONIC SOFAMOR DANEK, INC. BLOCK CEMENT RESTRICTOR (CR) - TITANIUM 10/04/2001
K013663 MEDTRONIC SOFAMOR DANEK, INC. CEMENT RESTRICTOR 12/05/2001
K012255 MEDTRONIC SOFAMOR DANEK, INC. MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR 08/01/2001
K011998 MEDTRONIC SOFAMOR DANEK, INC. METRONIC SOFAMOR DANEK CEMENT RESTRICTOR 07/26/2001
K003718 MEDTRONIC SOFAMOR DANEK, INC. TITANIUM CEMENT RESTRICTOR (TCR) 02/14/2001
K051836 MILLENIUM BIOLOGIX, INC. SKELITE RESORBABLE CEMENT RESTRICTOR 11/21/2005
K021788 NEW BUSINESS DEVELOPMENT, LLC NBD CEMENT RESTRICTOR DEVICE 10/04/2002
K051607 NOVASPINE LLC NOVASPINE CEMENT RESTRICTOR NSCR 10/07/2005
K032180 NUVASIVE, INC. NUVASIVE CEMENT RESTRICTOR 10/07/2003
K041382 OSTEOBIOLOGICS, INC. POLYGRAFT BGS; BONE GRAFT SUBSTITUTE 06/17/2005
K030608 OSTEOIMPLANT TECHNOLOGY, INC. OTI BONE CEMENT PLUG 06/12/2003
K965056 OSTEONICS CORP. OSTEONICS SCREW HOLE PLUGS 02/28/1997
K040276 QUANTUM ORTHOPEDICS QUANTUM CEMENT RESTRICTOR 04/30/2004
K052367 SCIENT'X SCIENT'X CEMENT RESTRICTOR 10/05/2005
K020836 SIGNUS MEDICAL LLC. RABEA CEMENT RESTRICTOR 06/11/2002
K990345 SIGNUS MEDIZINTECHNIK GMBH RABEA DEVICE, MODEL PXXXXXX 07/30/1999
K022218 SPINAL CONCEPTS, INC. CADENCE CEMENT RESTRICTOR 08/12/2002
K023647 SPINAL CONCEPTS, INC. CADENCE PEEK CEMEENT RESTRICTOR 11/27/2002
K021719 SPINAL CONCEPTS, INC. FORTITUDE CEMENT RESTRICTOR 08/15/2002
K031837 SPINAL CONCEPTS, INC. MODIFICATION TO FORTITUDE CEMENT RESTRICTOR 07/24/2003
K031318 SPINAL CONCEPTS, INC. TRAXIS CEMENT RESTRICTOR 08/22/2003
K060132 SPINAL USA SPINAL USA CEMENT RESTRICTOR SYSTEM 03/16/2006
K030871 SPINE NEXT SA FIDJI LARGE CEMENT RESTRICTOR 12/22/2003
K030767 SPINE NEXT SA FIDJI SMALL CEMENT RESTRICTOR 12/22/2003
K033953 SPINEOLOGY, INC. OPTIMESH 500E CEMENT RESTRICTOR 07/06/2004
K020344 SULZER SPINE-TECH RPX TITANIUM CEMNT RESTRICTOR 05/02/2002
K012462 THEKEN SURGICAL,LLC THEKEN LARGE CEMENT RESTRICTOR 10/29/2001
K012278 THEKEN SURGICAL,LLC THEKEN SMALL CEMENT RESTRICTOR 10/17/2001


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