ClearanceBrief
510(k) K051195 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

GRAFTON DBM

ApplicantOsteotech, Inc., Eatontown NJ, US
DecisionSubstantially Equivalent, Dec 16, 2005
ReceivedMay 10, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K051195

DateFirm and productCodeLinked 510(k)
Oct 9, 2026Medtronic Sofamor Danek USA Inc
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical for
Open, Classified
MBPNone listed
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Open, Classified
MBPNone listed
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Open, Classified
MBPNone listed
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Open, Classified
MBPNone listed
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
Open, Classified
MBPNone listed
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Open, Classified
MBPNone listed
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Open, Classified
MBPNone listed
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PU
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRU
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d)
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d)
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, R
Open, Classified
MBPNone listed
Feb 12, 2014Medtronic Sofamor Danek USA Inc
Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft.
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft.
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograf
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograf
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allo
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) a
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matr
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone mat
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone mat
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intende
Terminated
MBPNone listed
Oct 18, 2012Osteotech Inc
Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft
Terminated
MBPNone listed
Jan 11, 2012Osteotech Inc
Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts
Terminated
MBPNone listed
Jan 11, 2012Osteotech Inc
Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts
Terminated
MBPNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.