FDA 510(k)

Catalyst OrthoScience R1 Reverse Shoulder System

K-Number: K202611 · 2021-02-12

Decision Date2021-02-12

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Catalyst OrthoScience R1 Reverse Shoulder System is a medical device manufactured by Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2021-02-12 under approval number K202611. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catalyst OrthoScience R1 Reverse Shoulder System?

Catalyst OrthoScience R1 Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2021-02-12. It is manufactured by Catalyst Orthoscience, Inc.. The 510(k) number is K202611.

When was Catalyst OrthoScience R1 Reverse Shoulder System approved by the FDA?

Catalyst OrthoScience R1 Reverse Shoulder System received FDA 510(k) clearance on 2021-02-12, under approval number K202611.

What company makes Catalyst OrthoScience R1 Reverse Shoulder System?

Catalyst OrthoScience R1 Reverse Shoulder System is manufactured by Catalyst Orthoscience, Inc..

What is the FDA product code for Catalyst OrthoScience R1 Reverse Shoulder System?

The FDA product code for Catalyst OrthoScience R1 Reverse Shoulder System is PHX.

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Other Devices by Catalyst Orthoscience, Inc.

K181287Catalyst CSR Shoulder System K173812Catalyst CSR 3 Peg Glenoids K191811Catalyst OrthoScience CSR Shoulder System K182500Catalyst CSR Press-Fit Humeral Components K211991Catalyst R1 Reverse Shoulder System K222317Catalyst EA Convertible Stemmed Shoulder

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.