The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Dbx Demineralized Bone Matrix Putty/paste/mix.
| Device ID | K053218 |
| 510k Number | K053218 |
| Device Name: | DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| Subsequent Product Code | GXP |
| Subsequent Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-17 |
| Decision Date | 2006-12-28 |
| Summary: | summary |