The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Dbx Demineralized Bone Matrix Mix.
| Device ID | K063676 |
| 510k Number | K063676 |
| Device Name: | DBX DEMINERALIZED BONE MATRIX MIX |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Contact | Nancy Bennewitz |
| Correspondent | Nancy Bennewitz MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-11 |
| Decision Date | 2007-03-05 |
| Summary: | summary |