Arthrex Univers Apex, Size 5 Stem

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 Univers Apex, Size 5 Stem.

Pre-market Notification Details

Device IDK153115
510k NumberK153115
Device Name:Arthrex Univers Apex, Size 5 Stem
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples,  FL  34108 -1945
ContactCourtney Smith
CorrespondentCourtney Smith
ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples,  FL  34108 -1945
Product CodeKWS  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-28
Decision Date2015-11-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.