MONTAGE-QS Settable, Resorbable Hemostatic Bone

Wax, Bone

Orthocon, Inc.

The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Montage-qs Settable, Resorbable Hemostatic Bone.

Pre-market Notification Details

Device IDK191140
510k NumberK191140
Device Name:MONTAGE-QS Settable, Resorbable Hemostatic Bone
ClassificationWax, Bone
Applicant Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington,  NY  10533
ContactHoward L. Schrayer
CorrespondentHoward L. Schrayer
Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington,  NY  10533
Product CodeMTJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-30
Decision Date2019-07-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.