Arthrex Eclipse Shoulder Prosthesis System

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

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 IDK201542
510k NumberK201542
Device Name:Arthrex Eclipse Shoulder Prosthesis System
ClassificationProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
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 CodePKC  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-09
Decision Date2020-07-08

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