ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY

Wax, Bone

ORTHOCON, LLC

The following data is part of a premarket notification filed by Orthocon, Llc with the FDA for Orthocon Llc Orthostat Hemostatic Bone Putty.

Pre-market Notification Details

Device IDK043260
510k NumberK043260
Device Name:ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
ClassificationWax, Bone
Applicant ORTHOCON, LLC 167 STONE HILL ROAD Colts Neck,  NY 
ContactHoward Schrayer
CorrespondentHoward Schrayer
ORTHOCON, LLC 167 STONE HILL ROAD Colts Neck,  NY 
Product CodeMTJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2004-11-24
Decision Date2005-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850391007160 K043260 000
00850391007030 K043260 000
00850391007153 K043260 000

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