ARTHREX SMALL FRAGMENT PLATES AND SCREWS

Plate, Fixation, Bone

ARTHREX, INC.

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

Pre-market Notification Details

Device IDK040907
510k NumberK040907
Device Name:ARTHREX SMALL FRAGMENT PLATES AND SCREWS
ClassificationPlate, Fixation, Bone
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactSally Foust
CorrespondentSally Foust
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 Received2004-04-07
Decision Date2004-07-01
Summary:summary

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