Arthrex Mini Fragment System

Plate, Fixation, Bone

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Mini Fragment System.

Pre-market Notification Details

Device IDK220937
510k NumberK220937
Device Name:Arthrex Mini Fragment System
ClassificationPlate, Fixation, Bone
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactStacy Valdez
CorrespondentStacy Valdez
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-31
Decision Date2022-06-29

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