Catalyst EA Convertible Stemmed Shoulder

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

Catalyst OrthoScience, Inc.

The following data is part of a premarket notification filed by Catalyst Orthoscience, Inc. with the FDA for Catalyst Ea Convertible Stemmed Shoulder.

Pre-market Notification Details

Device IDK222317
510k NumberK222317
Device Name:Catalyst EA Convertible Stemmed Shoulder
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
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 CodeKWS  
Subsequent Product CodeHSD
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-02
Decision Date2022-11-10

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