ARTHREX FRACTURE PLATES

Plate, Fixation, Bone

ARTHREX, INC.

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

Pre-market Notification Details

Device IDK123241
510k NumberK123241
Device Name:ARTHREX FRACTURE PLATES
ClassificationPlate, Fixation, Bone
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactCourtney Smith
CorrespondentCourtney Smith
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-17
Decision Date2013-04-05
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.