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 |