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FDA 510(k)

Catalyst EA Convertible Stemmed Shoulder

K-Number: K222317 · 2022-11-10

ApplicantCatalyst Orthoscience, Inc.
Decision Date2022-11-10
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyst EA Convertible Stemmed Shoulder is a medical device manufactured by Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2022-11-10 under approval number K222317. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catalyst EA Convertible Stemmed Shoulder?

Catalyst EA Convertible Stemmed Shoulder is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by Catalyst Orthoscience, Inc.. The 510(k) number is K222317.

When was Catalyst EA Convertible Stemmed Shoulder approved by the FDA?

Catalyst EA Convertible Stemmed Shoulder received FDA 510(k) clearance on 2022-11-10, under approval number K222317.

What company makes Catalyst EA Convertible Stemmed Shoulder?

Catalyst EA Convertible Stemmed Shoulder is manufactured by Catalyst Orthoscience, Inc..

What is the FDA product code for Catalyst EA Convertible Stemmed Shoulder?

The FDA product code for Catalyst EA Convertible Stemmed Shoulder is KWS.

Related Clinical Trials

NCT04968405 Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty COMPLETED

Other Devices by Catalyst Orthoscience, Inc.

K181287Catalyst CSR Shoulder System 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

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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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