Catalyst OrthoScience R1 Reverse Shoulder System

Shoulder Prosthesis, Reverse Configuration

Catalyst OrthoScience, Inc.

The following data is part of a premarket notification filed by Catalyst Orthoscience, Inc. with the FDA for Catalyst Orthoscience R1 Reverse Shoulder System.

Pre-market Notification Details

Device IDK202611
510k NumberK202611
Device Name:Catalyst OrthoScience R1 Reverse Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Catalyst OrthoScience, Inc. 14710 Tamiami Trail North Naples,  FL  34110
ContactDale Davison
CorrespondentDale Davison
Catalyst OrthoScience, Inc. 14710 Tamiami Trail North Naples,  FL  34110
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-09
Decision Date2021-02-12

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