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 |
| K242799 | LifeNet Health | PliaFX Flo | 11/21/2024 |
| 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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