Arthrex Eclipse Shoulder Prosthesis System

Total Shoulder Arthroplasty System

Arthrex Inc.

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

Pre-market Notification Details

Device IDK183194
510k NumberK183194
Device Name:Arthrex Eclipse Shoulder Prosthesis System
ClassificationTotal Shoulder Arthroplasty System
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 CodeQHQ  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2019-07-26
Summary:summary

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