FDA 510(k)

Catalyst EA Convertible Stemmed Shoulder

K-Number: K222317 · 2022-11-10

Decision Date2022-11-10

Product CodeKWS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Catalyst EA Convertible Stemmed Shoulder 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 2022-11-10 under 510(k) 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. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K222317.

When did Catalyst EA Convertible Stemmed Shoulder receive FDA 510(k) clearance?

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

Who is the listed applicant for Catalyst EA Convertible Stemmed Shoulder?

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 EA Convertible Stemmed Shoulder?

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

Other records listing Catalyst Orthoscience, Inc. as applicant

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.

K252418Catalyst F1x Shoulder System K234105Catalyst F1x Shoulder System K232583Catalyst R1 Reverse Shoulder System K223655Catalyst R1 Reverse Shoulder System K213349Catalyst R1 Reverse Shoulder System K211991Catalyst R1 Reverse Shoulder System

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Related Devices (Code: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.