510(k) K042707 ยท NUN Bone Grafting Material, Human Source
GRAFTON PLUS DBM PASTE
| Applicant | Osteotech, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Nov 30, 2005 |
| Received | Sep 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042707
| 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 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.