The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Dbx-h Hemostatic Demineralized Bone Matrix Putty.
| Device ID | K061131 |
| 510k Number | K061131 |
| Device Name: | DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | ORTHOCON, INC. 167 STONE HILL ROAD Colts Neck, NJ 07722 |
| Contact | Howard Schrayer |
| Correspondent | Howard Schrayer ORTHOCON, INC. 167 STONE HILL ROAD Colts Neck, NJ 07722 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-24 |
| Decision Date | 2007-02-08 |
| Summary: | summary |