Product code MBP

Device name: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Medical specialty: Orthopedic
Device class: 2
Regulation number: 888.3045
Review panel: OR
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K242799	PliaFX Flo	Lifenet Health	2024-11-21
K143547	Vivorte Trabexus EB	Vivorte, Inc.	2015-01-14
K130703	VIVORTE BVF	Vivorte, Inc.	2013-09-12
K130498	OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY	Bacterin International, Inc.	2013-05-31
K122513	CLEARED UNDER GRAFTON II EDBM	Medtronic Sofamor Danek, Inc.	2013-03-06
K113728	SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY	Hans Biomed Corp.	2012-11-15
K103742	ACCELL EVO3 (FORMERLY ACCELL A2I)	Integra Life Sciences	2011-03-17
K091193	ACCELL EVO3C	Isotis Orthobiologics, Inc.	2009-08-10
K080399	DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE	Musculoskeletal Transplant Foundation	2008-10-10
K081817	ACCELL TBM-R	Isotis Orthobiologics, Inc.	2008-09-24
K080405	SYGNAL DBM	Musculoskeletal Transplant Foundation	2008-08-28
K080329	CAP PLUS, EQUIVABONE, CAP/DBM	Etex Corp.	2008-04-28
K073329	SYGNAL DBM	Musculoskeletal Transplant Foundation	2008-02-28
K063685	OPTECURE; OPTECURE + CCC	Exactech, Inc.	2007-06-07
K063676	DBX DEMINERALIZED BONE MATRIX MIX	Musculoskeletal Transplant Foundation	2007-03-05
K061131	DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY	Orthocon, Inc.	2007-02-08
K061982	PLEXUR P	Osteotech, Inc.	2007-02-07
K062205	DBX STRIP	Musculoskeletal Transplant Foundation	2007-02-05
K060794	PROGENIX DBM PUTTY AND PASTE	Medtronic Sofamor Danek	2006-12-18
K061668	OPTECURE +CCC	Exactech, Inc.	2006-09-12
K060180	BIOSET XC	Regeneration Technologies, Inc.	2006-09-06
K060161	AFT ALLOGRAFT FILLER TUBE	Musculoskeletal Transplant Foundation	2006-03-21
K050806	OPTECURE	Exactech, Inc.	2006-02-08
K053642	OSTEOSET DBM PELLETS	Wrightmedicaltechnologyinc	2006-01-26
K042829	DBX STRIP	Musculoskeletal Transplant Foundation	2006-01-13
K052735	ALLOCRAFT DBM	Lifecell Corp.	2005-12-28
K051195	GRAFTON DBM	Osteotech, Inc.	2005-12-16
K043209	VIAGRAF DBM PASTE	Osteotech, Inc.	2005-12-05
K050642	ORTHOBLAST II PUTTY AND PASTE	Isotis Orthobiologics, Inc.	2005-12-05
K053098	OPTIUM DBM GEL AND PUTTY	Lifenet	2005-11-28

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00613994247612	PROGENIX® PUTTY and PROGENIX® PLUS	MEDTRONIC SOFAMOR DANEK, INC.	2019-03-29
00613994985675	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985828	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985811	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985804	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985781	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985774	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985767	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985750	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985743	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985736	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985729	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985712	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985705	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985699	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985682	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994236401	PROGENIX® PUTTY and PROGENIX® PLUS	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985668	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985651	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985644	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985514	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985507	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985491	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985484	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985477	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985460	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985453	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994985446	GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994236425	PROGENIX® PUTTY and PROGENIX® PLUS	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20
00613994236418	PROGENIX® PUTTY and PROGENIX® PLUS	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-20

Product code MBP

Related 510(k) Records#

Related GUDID Devices#