The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Dbx Demineralized Bone Matrix Putty, Bone Matrix Paste And Bone Matrix Mix.
| Device ID | K040262 |
| 510k Number | K040262 |
| Device Name: | DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY ST Edison, NJ 08837 |
| Contact | Kathleen M Laffan |
| Correspondent | Kathleen M Laffan MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY ST Edison, NJ 08837 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-04 |
| Decision Date | 2005-03-17 |
| Summary: | summary |