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FDA 510(k)

Catalyst OrthoScience CSR Shoulder System

K-Number: K191811 · 2019-09-11

ApplicantCatalyst Orthoscience, Inc.
Decision Date2019-09-11
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyst OrthoScience CSR Shoulder System is a medical device manufactured by Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2019-09-11 under approval 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. It is manufactured by Catalyst Orthoscience, Inc.. The 510(k) number is K191811.

When was Catalyst OrthoScience CSR Shoulder System approved by the FDA?

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

What company makes Catalyst OrthoScience CSR Shoulder System?

Catalyst OrthoScience CSR Shoulder System is manufactured by Catalyst Orthoscience, Inc..

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

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Catalyst Orthoscience, Inc.

K181287Catalyst CSR Shoulder System K173812Catalyst CSR 3 Peg Glenoids K182500Catalyst CSR Press-Fit Humeral Components K211991Catalyst R1 Reverse Shoulder System K202611Catalyst OrthoScience R1 Reverse Shoulder System K222317Catalyst EA Convertible Stemmed Shoulder

View all 12 devices →

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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