FDA.reportPublic FDA data

Bone matrix implant, human-derived

Definition
An sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.
GUDID devices
66
Last updated
2020-09-22 07:46:45

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M386TXG051Trel-X GelIntegra Lifesciences CorporationTXG052015-09-22
M386TXG101Trel-X GelIntegra Lifesciences CorporationTXG102015-09-22
M386XPRES1051Trel X-Press 100Integra Lifesciences CorporationXPRES1052015-09-22
M386XPRES1101Trel X-Press 100Integra Lifesciences CorporationXPRES1102015-09-22
M386XPRES1251Trel X-Press 100Integra Lifesciences CorporationXPRES1252015-09-22
M386XPRES3051Trel X-Press 300Integra Lifesciences CorporationXPRES3052015-09-25
M386XPRES3251Trel X-Press 300Integra Lifesciences CorporationXPRES3252015-09-25
M386XPRES3C101Trel XPress 300CIntegra Lifesciences CorporationXPres3c102015-09-25
M386TXCPA011Trel-XC PasteIntegra Lifesciences CorporationTXCPA012015-09-22
M386TXCPA031Trel-XC PasteIntegra Lifesciences CorporationTXCPA032015-09-22
M386TXCPA081Trel-XC PasteIntegra Lifesciences CorporationTXCPA082015-09-22
M386TXCPY051Trel-XC PuttyIntegra Lifesciences CorporationTXCPY052015-09-22
M386TXCPY101Trel-XC PuttyIntegra Lifesciences CorporationTXCPY102015-09-22
M386TXG011Trel-X GelIntegra Lifesciences CorporationTXG012015-09-22
M386TXP051Trel-X PuttyIntegra Lifesciences CorporationTXP052015-09-22
M386TXP101Trel-X PuttyIntegra Lifesciences CorporationTXP102015-09-22
M3860220000051Dynagraft II GelISOTIS ORTHOBIOLOGICS, INC.02-2000-0052015-09-24
M3860220000101Dynagraft II GelISOTIS ORTHOBIOLOGICS, INC.02-2000-0102015-09-24
M3860220000501Dynagraft II GelISOTIS ORTHOBIOLOGICS, INC.02-2000-0502015-09-24
M3860220001001Dynagraft II GelISOTIS ORTHOBIOLOGICS, INC.02-2000-1002015-09-24
M3860220100101Dynagraft II PuttyISOTIS ORTHOBIOLOGICS, INC.02-2010-0102015-09-24
M3860220100251Dynagraft II PuttyISOTIS ORTHOBIOLOGICS, INC.02-2010-0252015-09-24
M3860220100501Dynagraft II PuttyISOTIS ORTHOBIOLOGICS, INC.02-2010-0502015-09-24
M3860220101001Dynagraft II PuttyISOTIS ORTHOBIOLOGICS, INC.02-2010-1002015-09-24
M3860230000051Accell ConnexusISOTIS ORTHOBIOLOGICS, INC.02-3000-0052015-09-24
M3860230000101Accell ConnexusISOTIS ORTHOBIOLOGICS, INC.02-3000-0102015-09-24
M3860230000251Accell ConnexusISOTIS ORTHOBIOLOGICS, INC.02-3000-0252015-09-24
M3860230000501Accell ConnexusISOTIS ORTHOBIOLOGICS, INC.02-3000-0502015-09-24
M3860230001001Accell ConnexusISOTIS ORTHOBIOLOGICS, INC.02-3000-1002015-09-24
M3860250000251Accell Evo3 PuttyISOTIS ORTHOBIOLOGICS, INC.02-5000-0252015-09-24
M3860250000501Accell Evo3 PuttyISOTIS ORTHOBIOLOGICS, INC.02-5000-0502015-09-24
M3860250001001Accell Evo3 PuttyISOTIS ORTHOBIOLOGICS, INC.02-5000-1002015-09-24
M3860260000251Accell Evo3 C PuttyISOTIS ORTHOBIOLOGICS, INC.02-6000-0252015-09-24
M3860260000501Accell Evo3 C PuttyISOTIS ORTHOBIOLOGICS, INC.02-6000-0502015-09-24
M3860260001001Accell Evo3 C PuttyISOTIS ORTHOBIOLOGICS, INC.02-6000-1002015-09-24
M3860221000051Orthoblast II PasteISOTIS ORTHOBIOLOGICS, INC.02-2100-0052015-09-24
M3860221000101Orthoblast II PasteISOTIS ORTHOBIOLOGICS, INC.02-2100-0102015-09-24
M3860221000301Orthoblast II PasteISOTIS ORTHOBIOLOGICS, INC.02-2100-0302015-09-24
M3860221000801Orthoblast II PasteISOTIS ORTHOBIOLOGICS, INC.02-2100-0802015-09-24
M3860221100501Orthoblast II PuttyISOTIS ORTHOBIOLOGICS, INC.02-2110-0502015-09-24
M3860221101001Orthoblast II PuttyISOTIS ORTHOBIOLOGICS, INC.02-2110-1002015-09-24
M3860240005201Accell TBMISOTIS ORTHOBIOLOGICS, INC.02-4000-5202015-09-24
M3860240005501Accell TBMISOTIS ORTHOBIOLOGICS, INC.02-4000-5502015-09-24
M3860240007601Accell TBMISOTIS ORTHOBIOLOGICS, INC.02-4000-7602015-09-24
M386562000101OsteoSparx GelISOTIS ORTHOBIOLOGICS, INC.562000102015-09-24
M386562000501OsteoSparx GelISOTIS ORTHOBIOLOGICS, INC.562000502015-09-24
M386562001001OsteoSparx GelISOTIS ORTHOBIOLOGICS, INC.562001002015-09-24
M386562100101OsteoSparx PuttyISOTIS ORTHOBIOLOGICS, INC.562100102015-09-24
M386562100251OsteoSparx PuttyISOTIS ORTHOBIOLOGICS, INC.562100252015-09-24
M386562100501OsteoSparx PuttyISOTIS ORTHOBIOLOGICS, INC.562100502015-09-24
M386562101001OsteoSparx PuttyISOTIS ORTHOBIOLOGICS, INC.562101002015-09-24
M386562200101OsteoSparx C PasteISOTIS ORTHOBIOLOGICS, INC.562200102015-09-24
M386562200301OsteoSparx C PasteISOTIS ORTHOBIOLOGICS, INC.562200302015-09-24
M386562200801OsteoSparx C PasteISOTIS ORTHOBIOLOGICS, INC.562200802015-09-24
M386562300501OsteoSparx C PuttyISOTIS ORTHOBIOLOGICS, INC.562300502015-09-24
M386562301001OsteoSparx C PuttyISOTIS ORTHOBIOLOGICS, INC.562301002015-09-24
M386563000101OsteoSurge 100 PuttyISOTIS ORTHOBIOLOGICS, INC.563000102015-09-24
M386563000251OsteoSurge 100 PuttyISOTIS ORTHOBIOLOGICS, INC.563000252015-09-24
M386563000501OsteoSurge 100 PuttyISOTIS ORTHOBIOLOGICS, INC.563000502015-09-24
M386563001001OsteoSurge 100 PuttyISOTIS ORTHOBIOLOGICS, INC.563001002015-09-24
M386565000251OsteoSurge 300 PuttyISOTIS ORTHOBIOLOGICS, INC.565000252015-09-24
M386565000501OsteoSurge 300 PuttyISOTIS ORTHOBIOLOGICS, INC.565000502015-09-24
M386565001001OsteoSurge 300 PuttyISOTIS ORTHOBIOLOGICS, INC.565001002015-09-24
M386565100251OsteoSurge 300C PuttyISOTIS ORTHOBIOLOGICS, INC.565100252015-09-24
M386565100501OsteoSurge 300C PuttyISOTIS ORTHOBIOLOGICS, INC.565100502015-09-24
M386565101001OsteoSurge 300C PuttyISOTIS ORTHOBIOLOGICS, INC.565101002015-09-24