Arthrex Mesh Plates

Plate, Fixation, Bone

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Mesh Plates.

Pre-market Notification Details

Device IDK201677
510k NumberK201677
Device Name:Arthrex Mesh Plates
ClassificationPlate, Fixation, Bone
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactRebecca R Homan
CorrespondentRebecca R Homan
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeHRS  
Subsequent Product CodeHTY
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-19
Decision Date2020-09-02

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.