OVOMotion Reverse Shoulder Arthroplasty System

Shoulder Prosthesis, Reverse Configuration

Arthrosurface Inc.

The following data is part of a premarket notification filed by Arthrosurface Inc. with the FDA for Ovomotion Reverse Shoulder Arthroplasty System.

Pre-market Notification Details

Device IDK203375
510k NumberK203375
Device Name:OVOMotion Reverse Shoulder Arthroplasty System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Arthrosurface Inc. 28 Forge Parkway Franklin,  ME  02038
ContactDawn J. Wilson
CorrespondentDawn J. Wilson
Arthrosurface Inc. 28 Forge Parkway Franklin,  MA  02038
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-16
Decision Date2021-06-24

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