Catalyst CSR Shoulder System

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

CATALYST ORTHOSCIENCE LLC

The following data is part of a premarket notification filed by Catalyst Orthoscience Llc with the FDA for Catalyst Csr Shoulder System.

Pre-market Notification Details

Device IDK152825
510k NumberK152825
Device Name:Catalyst CSR Shoulder System
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant CATALYST ORTHOSCIENCE LLC 5867 WHISPERWOOD CT Naples,  FL  34110
ContactStephen Herrington
CorrespondentStephen Herrington
CATALYST ORTHOSCIENCE LLC 5867 WHISPERWOOD CT Naples,  FL  34110
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-29
Decision Date2016-05-11
Summary:summary

NIH GUDID Devices

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