Arthrex DynaNite Compression Plate

Plate, Fixation, Bone

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Dynanite Compression Plate.

Pre-market Notification Details

Device IDK193345
510k NumberK193345
Device Name:Arthrex DynaNite Compression Plate
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  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-03
Decision Date2020-07-08

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