Arthrex Shoulder System

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Arthrex Inc.

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

Pre-market Notification Details

Device IDK171841
510k NumberK171841
Device Name:Arthrex Shoulder System
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactDavid L. Rogers
CorrespondentDavid L. Rogers
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeKWS  
Subsequent Product CodeHSD
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-20
Decision Date2018-03-29
Summary:summary

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