Product Code: MBP


Products Classified as MBP

4619Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)Resorbable Calcium Salt Bone Void Filler Device.

Total Product Life Cycle (TPLC) Devices

4619Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)Resorbable Calcium Salt Bone Void Filler Device.

FDA Consensus Standards

Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) [37410]21 CFR §888.3045 🔎
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) [37411]21 CFR §888.3045 🔎
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) [34067]21 CFR §888.3045 🔎
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) [35613]21 CFR §888.3045 🔎
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) [34065]21 CFR §888.3045 🔎
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) [33611]21 CFR §888.3045 🔎
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) [36749]21 CFR §888.3045 🔎

Pre-market Notifications for MBP

K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation
K143547Vivorte Trabexus EBVIVORTE, INC
K130703VIVORTE BVFVIVORTE, INC
K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBACTERIN INTERNATIONAL INC.
K122513CLEARED UNDER GRAFTON II EDBMMEDTRONIC SOFAMOR DANEK, INC.
K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYHANS BIOMED CORP.
K103742ACCELL EVO3 (FORMERLY ACCELL A2I)INTEGRA LIFESCIENCES
K091193ACCELL EVO3CISOTIS ORTHOBIOLOGICS, INC
K081817ACCELL TBM-RISOTIS ORTHOBIOLOGICS, INC
K080399DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTEMUSCULOSKELETAL TRANSPLANT FOUNDATION
K080405SYGNAL DBMMUSCULOSKELETAL TRANSPLANT FOUNDATION
K080329CAP PLUS, EQUIVABONE, CAP/DBMETEX CORP.
K073329SYGNAL DBMMUSCULOSKELETAL TRANSPLANT FOUNDATION
K063685OPTECURE; OPTECURE + CCCEXACTECH, INC.
K063676DBX DEMINERALIZED BONE MATRIX MIXMUSCULOSKELETAL TRANSPLANT FOUNDATION

Global Unique Device Identification Database

00613994236425Filler, bone void, osteoinduction (w/o human growth factor)
00613994236401Filler, bone void, osteoinduction (w/o human growth factor)
00643169134393Filler, bone void, osteoinduction (w/o human growth factor)
00643169134386Filler, bone void, osteoinduction (w/o human growth factor)
00643169134379Filler, bone void, osteoinduction (w/o human growth factor)
00643169134362Filler, bone void, osteoinduction (w/o human growth factor)
00643169134348Filler, bone void, osteoinduction (w/o human growth factor)
00643169134324Filler, bone void, osteoinduction (w/o human growth factor)
00643169123168Filler, bone void, osteoinduction (w/o human growth factor)
00643169123151Filler, bone void, osteoinduction (w/o human growth factor)
00643169123113Filler, bone void, osteoinduction (w/o human growth factor)
00643169123106Filler, bone void, osteoinduction (w/o human growth factor)
00643169123069Filler, bone void, osteoinduction (w/o human growth factor)
00643169123038Filler, bone void, osteoinduction (w/o human growth factor)
00643169123021Filler, bone void, osteoinduction (w/o human growth factor)

Maude Adverse Events

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBACTERIN INTERNATIONAL, INC.2019-05-08
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBACTERIN INTERNATIONAL, INC.2019-05-08
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBACTERIN INTERNATIONAL, INC.2019-05-08
STRYKER DBM 5 CC GELALLOSOURCE2018-10-08
STRYKER DBM 5 CC GELALLOSOURCE2018-10-08
XEMPLIFI DBM PLUSALLOSOURCE2018-01-02
XEMPLIFI DBM PLUSALLOSOURCE2018-01-02
XEMPLIFI DBM PUTTYALLOSOURCE2018-01-02
XEMPLIFI DBM PLUSALLOSOURCE2018-01-02
XEMPLIFI DBM PUTTYALLOSOURCE2018-01-02
XEMPLIFI DBM PUTTYALLOSOURCE2018-01-02
XEMPLIFI DBM PUTTYALLOSOURCE2018-01-02
DBM PUTTY 5.0CC, AXOGRAFTBACTERIN INTERNATIONAL, INC.2017-09-14
BIO DBM PUTTY 10CCSTRYKER SPINE-US2017-04-26
OSTEOSELECTBACTERIN INTERNATIONAL, INC.2017-03-21
DBX PUTTY, 10CCMUSCULOSKELETAL TRANSPLANT FOUNDATION2017-02-28
DBX PUTTY, 10CCMUSCULOSKELETAL TRANSPLANT FOUNDATION2017-02-28
OSTEOSURGE 300SEASPINE ORTHOPEDICS CORPORATION2016-11-22
BIO DBM PUTTY 1CCSTRYKER SPINE-US2016-10-27
ALLOGRAFT EVANS WEDGE 10X22X20MMSTRYKER ORTHOBIOLOGICS-MALVERN2016-08-09
OSTEOSURGE 300 -ACCELL EVO3 FAMILYISOTIS ORTHOBIOLOGICS, INC2016-07-29
DBX PUTTY , 5CC (DEMINERALIZED BONE MATRIX)MUSCULOSKELETAL TRANSPLANT FOUNDATION2016-07-26
DBXBONE VOID FILLERMUSCULOSKELETAL TRANSPLANT FOUNDATION2016-03-22
OPTECURE ALLOGRAFT, 5CCEXACTECH, INC2015-11-12
XEMFLIFI DBM PLUS, 3CCGLOBUS MEDICAL, INC.2015-08-07
GRAFTON DBMOSTEOTECH. INC2015-07-03
ORTHOBLAST-II PASTEISOTIS ORTHOBIOLOGICS, INC2015-06-02
ORTHOBLAST-II PASTEISOTIS ORTHOBIOLOGICS, INC2015-04-13
ORTHOBLAST-II PASTEISOTIS ORTHOBIOLOGICS, INC2015-04-13
ORTHOBLAST-II PASTEISOTIS ORTHOBIOLOGICS, INC2015-04-13
ORTHOBLAST-II PASTEISOTIS ORTHOBIOLOGICS, INC2015-04-13
ORTHOBLAST-II PASTEISOTIS ORTHOBIOLOGICS, INC2015-04-13
ORTHOBLAST-II PASTEISOTIS ORTHOBIOLOGICS, INC2015-04-10
GRAFTONOSTEOTECH2015-01-21
NAFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)MEDTRONIC SOFAMOR DANEK USA, INC2014-11-05
N/AFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)MEDTRONIC SOFAMOR DANEK USA, INC2014-11-04
ACCELL EVO3, 2.5CCISOTIS ORTHOBIOLOGICS, INC2014-10-07
GRAFTON DBMOSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)2014-07-14
NOT REPORTEDOSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)2014-06-11
GRAFTON DBMOSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)2014-06-05
GRAFTON DBMOSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)2014-05-29
GRAFTON DBMOSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)2014-05-22
MEDTRONIC GRAFTON ALLOGRAFT PUTTYMEDTRONIC2014-05-05
PROGENIX(R) PLUSMEDTRONIC SOFAMOR DANEK USA, INC2014-05-02
STIMULAN RAPID CUREBIOCOMPOSITES LTD.2014-04-14
EXFUSEHANS BIOMED CORP.2014-03-20
OPTIPLUG - UNK SIZEISOTIS ORTHOBIOLOGICS, INC2014-03-12
TREL-XPRESS 300 5CCTIS ORTHOBIOLOGICS, INC. ISOTIS ORTHOBIOLOGICS, INC2014-01-29
TREL-XPRESS 300 2.5CCISOTIS ORTHOBIOLOGICS, INC2014-01-29
GRAFTON DBMOSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)2013-12-20
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