510(k) K082615 ยท MQV Filler, Bone Void, Calcium Compound
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
| Applicant | Osteotech, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Oct 16, 2008 |
| Received | Sep 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2023 | Medtronic Sofamor Danek USA Inc Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile. Open, Classified |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.