510(k) K043048 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
GRAFTON PLUS DBM PASTE
| Applicant | Osteotech, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Nov 23, 2005 |
| Received | Nov 4, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043048
| 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 f 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 |
| Apr 4, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Grafton Plus Paste
a) DBM S45001 GRAFTON 1CC PASTE, REF S45001;
b) DBM S45005 GRAFTON 5CC PASTE, REF S45005;
c) DBM S45010 GRAFTON 10CC PASTE, REF S45010;
d) DBM T45001 1CC PASTE GR Open, Classified |
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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.