FDA 510(k) Applications for Medical Device Product Code "MBP"
(Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))

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


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