OSLEOBRIDGE IDSF SPACER CONECTOR

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 Osleobridge Idsf Spacer Conector.

Pre-market Notification Details

Device IDK113303
510k NumberK113303
Device Name:OSLEOBRIDGE IDSF SPACER CONECTOR
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin,  DE D-12247
ContactEmmanuel Anapliois
CorrespondentEmmanuel Anapliois
MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin,  DE D-12247
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-09
Decision Date2011-12-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048266000804 K113303 000
04048266000798 K113303 000
04048266000781 K113303 000

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