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 |