DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY

Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

ORTHOCON, INC.

The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Dbx-h Hemostatic Demineralized Bone Matrix Putty.

Pre-market Notification Details

Device IDK061131
510k NumberK061131
Device Name:DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
ClassificationFiller, Bone Void, Osteoinduction (w/o Human Growth Factor)
Applicant ORTHOCON, INC. 167 STONE HILL ROAD Colts Neck,  NJ  07722
ContactHoward Schrayer
CorrespondentHoward Schrayer
ORTHOCON, INC. 167 STONE HILL ROAD Colts Neck,  NJ  07722
Product CodeMBP  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-24
Decision Date2007-02-08
Summary:summary

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