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FDA 510(k)

Catalyst F1x Shoulder System

K-Number: K234105 · 2024-04-05

ApplicantCatalyst Orthoscience, Inc.
Decision Date2024-04-05
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyst F1x 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 2024-04-05 under 510(k) number K234105. 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 F1x Shoulder System?

Catalyst F1x Shoulder System is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K234105.

When did Catalyst F1x Shoulder System receive FDA 510(k) clearance?

Catalyst F1x Shoulder System received FDA 510(k) clearance on 2024-04-05, under 510(k) number K234105.

Who is the listed applicant for Catalyst F1x 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 F1x Shoulder System?

The FDA product code for Catalyst F1x 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 SystemK232583Catalyst R1 Reverse Shoulder SystemK223655Catalyst R1 Reverse Shoulder SystemK222317Catalyst EA Convertible Stemmed ShoulderK213349Catalyst R1 Reverse Shoulder SystemK211991Catalyst R1 Reverse Shoulder System

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Related Devices (Code: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment 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, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive 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.

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