510(k) K051195 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
GRAFTON DBM
| Applicant | Osteotech, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | May 10, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051195
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Medtronic 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 |
MBP | None listed |
| Oct 25, 2023 | Medtronic Sofamor Danek USA Inc Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix Open, Classified |
MBP | None listed |
| Oct 25, 2023 | Medtronic Sofamor Danek USA Inc Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix Open, Classified |
MBP | None listed |
| Oct 25, 2023 | Medtronic Sofamor Danek USA Inc Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix Open, Classified |
MBP | None listed |
| Oct 25, 2023 | Medtronic Sofamor Danek USA Inc Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix Open, Classified |
MBP | None listed |
| Oct 25, 2023 | Medtronic Sofamor Danek USA Inc Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix Open, Classified |
MBP | None listed |
| Oct 25, 2023 | Medtronic Sofamor Danek USA Inc Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix Open, Classified |
MBP | None listed |
| Oct 25, 2023 | Medtronic 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 |
MBP | None listed |
| Apr 4, 2023 | Medtronic 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 |
MBP | None listed |
| Apr 4, 2023 | Medtronic 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 |
MBP | None listed |
| Apr 4, 2023 | Medtronic 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 |
MBP | None listed |
| Apr 4, 2023 | Medtronic 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 |
MBP | None listed |
| Apr 4, 2023 | Medtronic 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 |
MBP | None listed |
| Apr 4, 2023 | Medtronic 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 |
MBP | None listed |
| Apr 4, 2023 | Medtronic 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 |
MBP | None listed |
| Feb 12, 2014 | Medtronic 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Oct 18, 2012 | Osteotech 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 |
MBP | None listed |
| Jan 11, 2012 | Osteotech 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 |
MBP | None listed |
| Jan 11, 2012 | Osteotech 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 |
MBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.