OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM

Rod, Fixation, Intramedullary And Accessories

MERETE MEDICAL GMBH

The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System.

Pre-market Notification Details

Device IDK051965
510k NumberK051965
Device Name:OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant MERETE MEDICAL GMBH 5349 RED LEAF COURT Oviedo,  FL  32765
ContactCarl Knobloch
CorrespondentCarl Knobloch
MERETE MEDICAL GMBH 5349 RED LEAF COURT Oviedo,  FL  32765
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-20
Decision Date2006-06-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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