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FDA 510(k)

Catalyst CSR Shoulder System

K-Number: K152825 · 2016-05-11

ApplicantCatalyst Orthoscience, LLC
Decision Date2016-05-11
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyst CSR Shoulder System is a medical device manufactured by Catalyst Orthoscience, LLC. It received FDA 510(k) clearance on 2016-05-11 under approval number K152825. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catalyst CSR Shoulder System?

Catalyst CSR Shoulder System is a medical device that received FDA 510(k) clearance on 2016-05-11. It is manufactured by Catalyst Orthoscience, LLC. The 510(k) number is K152825.

When was Catalyst CSR Shoulder System approved by the FDA?

Catalyst CSR Shoulder System received FDA 510(k) clearance on 2016-05-11, under approval number K152825.

What company makes Catalyst CSR Shoulder System?

Catalyst CSR Shoulder System is manufactured by Catalyst Orthoscience, LLC.

What is the FDA product code for Catalyst CSR Shoulder System?

The FDA product code for Catalyst CSR Shoulder System is KWT.

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Related Devices (Code: KWT)

K161476SMR Shoulder SystemLima Corporate S.P.A. K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc. K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc. K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, 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.

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