OPTOSSOL COMPRESSION DEVICE SYSTEM

Pin, Fixation, Threaded

GENOSSIS, LLC

The following data is part of a premarket notification filed by Genossis, Llc with the FDA for Optossol Compression Device System.

Pre-market Notification Details

Device IDK140875
510k NumberK140875
Device Name:OPTOSSOL COMPRESSION DEVICE SYSTEM
ClassificationPin, Fixation, Threaded
Applicant GENOSSIS, LLC 29 WATER STREET, SUITE 305 Newburyport,  MA  01950
ContactBarry E Sands
CorrespondentBarry E Sands
GENOSSIS, LLC 29 WATER STREET, SUITE 305 Newburyport,  MA  01950
Product CodeJDW  
Subsequent Product CodeHTN
Subsequent Product CodeHWC
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-04
Decision Date2014-05-30
Summary:summary

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