Inset Reverse Total Shoulder System

Shoulder Prosthesis, Reverse Configuration

Shoulder Innovations, Inc.

The following data is part of a premarket notification filed by Shoulder Innovations, Inc. with the FDA for Inset Reverse Total Shoulder System.

Pre-market Notification Details

Device IDK210533
510k NumberK210533
Device Name:Inset Reverse Total Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Shoulder Innovations, Inc. 13827 Port Sheldon Street Holland,  MI  49424
ContactDon Running
CorrespondentDon Running
Shoulder Innovations, Inc. 13827 Port Sheldon Street Holland,  MI  49424
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-24
Decision Date2021-08-20

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