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MBP — Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Class II

FDA Device Classification

Classification Details

Product Code
MBP
Device Class
Class II
Regulation Number
888.3045
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242799lifenet healthPliaFX FloNovember 21, 2024
K143547vivorteVivorte Trabexus EBJanuary 14, 2015
K130703vivorteVIVORTE BVFSeptember 12, 2013
K130498bacterin internationalOSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYMay 31, 2013
K122513medtronic sofamor danekCLEARED UNDER GRAFTON II EDBMMarch 6, 2013
K113728hans biomedSURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYNovember 15, 2012
K103742integra life sciencesACCELL EVO3 (FORMERLY ACCELL A2I)March 17, 2011
K091193isotis orthobiologicsACCELL EVO3CAugust 10, 2009
K080399musculoskeletal transplant foundationDBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTEOctober 10, 2008
K081817isotis orthobiologicsACCELL TBM-RSeptember 24, 2008
K080405musculoskeletal transplant foundationSYGNAL DBMAugust 28, 2008
K080329etexCAP PLUS, EQUIVABONE, CAP/DBMApril 28, 2008
K073329musculoskeletal transplant foundationSYGNAL DBMFebruary 28, 2008
K063685exactechOPTECURE; OPTECURE + CCCJune 7, 2007
K063676musculoskeletal transplant foundationDBX DEMINERALIZED BONE MATRIX MIXMarch 5, 2007
K061131orthoconDBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTYFebruary 8, 2007
K061982osteotechPLEXUR PFebruary 7, 2007
K062205musculoskeletal transplant foundationDBX STRIPFebruary 5, 2007
K060794medtronic sofamor danekPROGENIX DBM PUTTY AND PASTEDecember 18, 2006
K061668exactechOPTECURE +CCCSeptember 12, 2006