OrthoButton FL

Fastener, Fixation, Nondegradable, Soft Tissue

Riverpoint Medical

The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Orthobutton Fl.

Pre-market Notification Details

Device IDK202399
510k NumberK202399
Device Name:OrthoButton FL
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Riverpoint Medical 825 NE 25th Ave. Portland,  OR  97232
ContactAmanda Cole
CorrespondentAmanda Cole
Riverpoint Medical 825 NE 25th Ave. Portland,  OR  97232
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2020-09-18

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