FDA.reportPublic FDA data

Human-derived demineralized bone matrix implant

Definition
An 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
984
Last updated
2026-10-17 23:38:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00191083045078RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5ccRti Surgical, Inc.ZR03052024-05-27
00191083045085RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1ccRti Surgical, Inc.ZR03012024-05-27
00191083045092RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2ccRti Surgical, Inc.ZR03022024-05-27
00191083045108RegenaVate™ Formable DBM RT, 1ccRti Surgical, Inc.ZR02012024-05-27
00191083045115RegenaVate™ Formable DBM RT, 2ccRti Surgical, Inc.ZR02022024-05-27
00613994236401PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.0005052015-07-20
00613994236418PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.0050012015-07-20
00613994236425PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.0050052015-07-20
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.0051102019-03-29
00613994391018PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.0060012015-07-20
00613994391025PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.0060022015-07-20
00613994391032PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.0060052015-07-20
00613994391049PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.0060102015-07-20
00613994985446GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P421602015-07-20
00613994985453GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P421102015-07-20
00613994985460GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P421002015-07-20
00613994985477GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P420902015-07-20
00613994985484GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P411502015-07-20
00613994985491GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P411302015-07-20
00613994985507GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P411202015-07-20
00613994985514GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P411102015-07-20
00613994985644GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P450102015-07-20
00613994985651GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P450052015-07-20
00613994985668GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P450012015-07-20
00613994985675GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P441502015-07-20
00613994985682GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P441452015-07-20
00613994985699GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P441352015-07-20
00613994985705GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P441252015-07-20
00613994985712GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P441152015-07-20
00613994985729GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P441052015-07-20
00613994985736GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P432042015-07-20
00613994985743GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P431102015-07-20
00613994985750GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P431052015-07-20
00613994985767GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P431032015-07-20
00613994985774GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P431022015-07-20
00613994985781GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P431012015-07-20
00613994985798GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P423082015-07-20
00613994985804GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P422802015-07-20
00613994985811GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P422752015-07-20
00613994985828GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P422102015-07-20
00613994985835GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.P422002015-07-20
00613994985842GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A441052015-07-20
00613994985859GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A432042015-07-20
00613994985866GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A431102015-07-20
00613994985873GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A431052015-07-20
00613994985880GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A431032015-07-20
00613994985897GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A431022015-07-20
00613994985903GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A431012015-07-20
00613994985910GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A423082015-07-20
00613994985927GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A422802015-07-20
00613994985934GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A422752015-07-20
00613994985941GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A422102015-07-20
00613994985958GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A422002015-07-20
00613994985965GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A421602015-07-20
00613994985972GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A421102015-07-20
00613994985989GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A421002015-07-20
00613994985996GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A420902015-07-20
00613994986009GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A411502015-07-20
00613994986016GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A411302015-07-20
00613994986023GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A411202015-07-20
00613994986030GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A411102015-07-20
00613994986146GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A441152015-07-20
00613994986153GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A441252015-07-20
00613994986160GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A441352015-07-20
00613994986177GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A441452015-07-20
00613994986184GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A441502015-07-20
00613994986191GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A450012015-07-20
00613994986207GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A450052015-07-20
00613994986214GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A450102015-07-20
00613994986467MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75090142015-12-01
00613994986474MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75090102015-12-01
00613994986481MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75090072015-12-01
00613994986498MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75092122015-12-01
00613994986504MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75092112015-12-01
00613994986511MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75092212015-12-01
00613994986528MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75092252015-12-01
00613994986535MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75091412015-12-01
00613994986542MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75091452015-12-01
00613994986559MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.75092152015-12-01
00643169001046GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)MEDTRONIC SOFAMOR DANEK, INC.A421502015-07-20