Arthrex UNIVERS REVERS COATED BASEPLATE

Shoulder Prosthesis, Reverse Configuration

Arthrex, Inc.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Univers Revers Coated Baseplate.

Pre-market Notification Details

Device IDK172371
510k NumberK172371
Device Name:Arthrex UNIVERS REVERS COATED BASEPLATE
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactCourtney Smith
CorrespondentCourtney Smith
Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-07
Decision Date2018-03-22
Summary:summary

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