FDA 510(k)

Catalyst OrthoScience CSR Shoulder System

K-Number: K191811 · 2019-09-11

Decision Date2019-09-11

Product CodeKWT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Catalyst OrthoScience CSR Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2019-09-11 under 510(k) number K191811. 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 OrthoScience CSR Shoulder System?

Catalyst OrthoScience CSR Shoulder System is a medical device that received FDA 510(k) clearance on 2019-09-11. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K191811.

When did Catalyst OrthoScience CSR Shoulder System receive FDA 510(k) clearance?

Catalyst OrthoScience CSR Shoulder System received FDA 510(k) clearance on 2019-09-11, under 510(k) number K191811.

Who is the listed applicant for Catalyst OrthoScience CSR Shoulder System?

The FDA 510(k) record lists Catalyst Orthoscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04968405Catalyst CSR Shoulder System for Semi or Total Shoulder ArthroplastyCOMPLETED

Other records listing Catalyst Orthoscience, Inc. as applicant

K252418Catalyst F1x Shoulder System K234105Catalyst F1x Shoulder System K232583Catalyst R1 Reverse Shoulder System K223655Catalyst R1 Reverse Shoulder System K222317Catalyst EA Convertible Stemmed Shoulder K213349Catalyst R1 Reverse Shoulder System

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Related Devices (Code: KWT)

K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH K241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH K223631Comprehensive Segmental Revision System(SRS)Biomet Orthopedics

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.