FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K130498 |
BACTERIN INTERNATIONAL INC. |
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY |
05/31/2013 |
K080329 |
ETEX CORP. |
CAP PLUS, EQUIVABONE, CAP/DBM |
04/28/2008 |
K050806 |
EXACTECH, INC. |
OPTECURE |
02/08/2006 |
K061668 |
EXACTECH, INC. |
OPTECURE +CCC |
09/12/2006 |
K063685 |
EXACTECH, INC. |
OPTECURE; OPTECURE + CCC |
06/07/2007 |
K113728 |
HANS BIOMED CORP. |
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY |
11/15/2012 |
K103742 |
INTEGRA LIFESCIENCES |
ACCELL EVO3 (FORMERLY ACCELL A2I) |
03/17/2011 |
K091193 |
ISOTIS ORTHOBIOLOGICS, INC |
ACCELL EVO3C |
08/10/2009 |
K081817 |
ISOTIS ORTHOBIOLOGICS, INC |
ACCELL TBM-R |
09/24/2008 |
K050642 |
ISOTIS ORTHOBIOLOGICS, INC |
ORTHOBLAST II PUTTY AND PASTE |
12/05/2005 |
K052735 |
LIFECELL CORP. |
ALLOCRAFT DBM |
12/28/2005 |
K053098 |
LIFENET |
OPTIUM DBM GEL AND PUTTY |
11/28/2005 |
K060794 |
MEDTRONIC SOFAMOR DANEK |
PROGENIX DBM PUTTY AND PASTE |
12/18/2006 |
K122513 |
MEDTRONIC SOFAMOR DANEK, INC. |
CLEARED UNDER GRAFTON II EDBM |
03/06/2013 |
K060161 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
AFT ALLOGRAFT FILLER TUBE |
03/21/2006 |
K063676 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
DBX DEMINERALIZED BONE MATRIX MIX |
03/05/2007 |
K080399 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE |
10/10/2008 |
K042829 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
DBX STRIP |
01/13/2006 |
K062205 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
DBX STRIP |
02/05/2007 |
K073329 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
SYGNAL DBM |
02/28/2008 |
K080405 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
SYGNAL DBM |
08/28/2008 |
K061131 |
ORTHOCON, INC. |
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY |
02/08/2007 |
K051195 |
OSTEOTECH, INC. |
GRAFTON DBM |
12/16/2005 |
K043048 |
OSTEOTECH, INC. |
GRAFTON PLUS DBM PASTE |
11/23/2005 |
K061982 |
OSTEOTECH, INC. |
PLEXUR P |
02/07/2007 |
K043209 |
OSTEOTECH, INC. |
VIAGRAF DBM PASTE |
12/05/2005 |
K060180 |
REGENERATION TECHNOLOGIES, INC. |
BIOSET XC |
09/06/2006 |
K130703 |
VIVORTE, INC |
VIVORTE BVF |
09/12/2013 |
K143547 |
VIVORTE, INC |
Vivorte Trabexus EB |
01/14/2015 |
K053642 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
OSTEOSET DBM PELLETS |
01/26/2006 |