Arthrex Pilon Fusion System

Plate, Fixation, Bone

Arthrex Inc.

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

Pre-market Notification Details

Device IDK203294
510k NumberK203294
Device Name:Arthrex Pilon Fusion System
ClassificationPlate, Fixation, Bone
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactSamantha Passman
CorrespondentSamantha Passman
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 Received2020-11-09
Decision Date2021-02-03

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