Arthrex Patella SuturePlates

Plate, Fixation, Bone

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Patella Sutureplates.

Pre-market Notification Details

Device IDK203834
510k NumberK203834
Device Name:Arthrex Patella SuturePlates
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  
Subsequent Product CodeHTY
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-30
Decision Date2021-03-25

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