MERETE DUOTHREADTM BONE SCREW

Screw, Fixation, Bone

MERETE MEDICAL GMBH

The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Merete Duothreadtm Bone Screw.

Pre-market Notification Details

Device IDK050924
510k NumberK050924
Device Name:MERETE DUOTHREADTM BONE SCREW
ClassificationScrew, Fixation, Bone
Applicant MERETE MEDICAL GMBH 269 WEST SEVENTY-FIRST STREET New York,  NY  10023
ContactJenik Radon
CorrespondentJenik Radon
MERETE MEDICAL GMBH 269 WEST SEVENTY-FIRST STREET New York,  NY  10023
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-13
Decision Date2005-05-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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04048266024718 K050924 000

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