Superelastic Staple

Staple, Fixation, Bone


The following data is part of a premarket notification filed by Neosteo with the FDA for Superelastic Staple.

Pre-market Notification Details

Device IDK192447
510k NumberK192447
Device Name:Superelastic Staple
ClassificationStaple, Fixation, Bone
Applicant Neosteo Malleve 2A, 1 Boulevard Jean Moulin Nantes,  FR 44 100
ContactAnne-cecile Grandremy
CorrespondentJ.d Webb
The OrthoMedix Group, Inc. 4313 W. 3800 S West Haven,  UT  84401
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-06
Decision Date2020-02-28

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