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FDA 510(k)

Catalyst CSR Press-Fit Humeral Components

K-Number: K182500 · 2019-01-11

ApplicantCatalyst Orthoscience, Inc.
Decision Date2019-01-11
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyst CSR Press-Fit Humeral Components is a medical device manufactured by Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2019-01-11 under approval number K182500. 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 Press-Fit Humeral Components?

Catalyst CSR Press-Fit Humeral Components is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Catalyst Orthoscience, Inc.. The 510(k) number is K182500.

When was Catalyst CSR Press-Fit Humeral Components approved by the FDA?

Catalyst CSR Press-Fit Humeral Components received FDA 510(k) clearance on 2019-01-11, under approval number K182500.

What company makes Catalyst CSR Press-Fit Humeral Components?

Catalyst CSR Press-Fit Humeral Components is manufactured by Catalyst Orthoscience, Inc..

What is the FDA product code for Catalyst CSR Press-Fit Humeral Components?

The FDA product code for Catalyst CSR Press-Fit Humeral Components is KWT.

Other Devices by Catalyst Orthoscience, Inc.

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Related Devices (Code: KWT)

K161476SMR Shoulder SystemLima Corporate S.P.A. K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC 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.

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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