ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR

Wax, Bone

ORTHOCON, INC.

The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Orthostat Bone Hemostat Matrix Applicator.

Pre-market Notification Details

Device IDK102762
510k NumberK102762
Device Name:ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
ClassificationWax, Bone
Applicant ORTHOCON, INC. 1 BRIDGE STREET, SUITE 121 Irvington,  NY  10533
ContactBrian Kunst
CorrespondentBrian Kunst
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 Received2010-09-24
Decision Date2011-02-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850391007054 K102762 000

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