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FDA 510(k)

Equinoxe® Shoulder System

K-Number: K243448 · 2025-08-01

ApplicantExactech, Inc.
Decision Date2025-08-01
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Equinoxe® Shoulder System is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2025-08-01 under approval number K243448. 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 Equinoxe® Shoulder System?

Equinoxe® Shoulder System is a medical device that received FDA 510(k) clearance on 2025-08-01. It is manufactured by Exactech, Inc.. The 510(k) number is K243448.

When was Equinoxe® Shoulder System approved by the FDA?

Equinoxe® Shoulder System received FDA 510(k) clearance on 2025-08-01, under approval number K243448.

What company makes Equinoxe® Shoulder System?

Equinoxe® Shoulder System is manufactured by Exactech, Inc..

What is the FDA product code for Equinoxe® Shoulder System?

The FDA product code for Equinoxe® Shoulder System is PHX.

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)

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, 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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