FDA 510(k)

Catalyst R1 Reverse Shoulder System

K-Number: K232583 · 2023-09-20

Decision Date2023-09-20

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Catalyst R1 Reverse 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 2023-09-20 under 510(k) number K232583. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catalyst R1 Reverse Shoulder System?

Catalyst R1 Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K232583.

When did Catalyst R1 Reverse Shoulder System receive FDA 510(k) clearance?

Catalyst R1 Reverse Shoulder System received FDA 510(k) clearance on 2023-09-20, under 510(k) number K232583.

Who is the listed applicant for Catalyst R1 Reverse 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 R1 Reverse Shoulder System?

The FDA product code for Catalyst R1 Reverse Shoulder System is PHX.

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 K223655Catalyst R1 Reverse Shoulder System K222317Catalyst EA Convertible Stemmed Shoulder K213349Catalyst R1 Reverse Shoulder System K211991Catalyst R1 Reverse Shoulder System

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Related Devices (Code: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet 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.