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FDA 510(k)

Catalyst CSR Shoulder System

K-Number: K181287 · 2018-07-12

ApplicantCatalyst Orthoscience, Inc.
Decision Date2018-07-12
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyst CSR Shoulder System is a medical device manufactured by Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2018-07-12 under approval number K181287. 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 2018-07-12. It is manufactured by Catalyst Orthoscience, Inc.. The 510(k) number is K181287.

When was Catalyst CSR Shoulder System approved by the FDA?

Catalyst CSR Shoulder System received FDA 510(k) clearance on 2018-07-12, under approval number K181287.

What company makes Catalyst CSR Shoulder System?

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

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

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

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

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.

K173812Catalyst CSR 3 Peg Glenoids K191811Catalyst OrthoScience CSR Shoulder System 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. 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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