The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Dbx Demineralized Bone Matrix Putty, Paste And Mix.
| Device ID | K040501 |
| 510k Number | K040501 |
| Device Name: | DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX |
| Classification | Bone Grafting Material, Human Source |
| Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Contact | Karen Hardwick |
| Correspondent | Karen Hardwick MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-26 |
| Decision Date | 2005-04-29 |
| Summary: | summary |