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FDA 510(k)

Exactech Equinoxe Small Reverse Shoulder System

K-Number: K180632 · 2018-07-25

ApplicantExactech, Inc.
Decision Date2018-07-25
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Equinoxe Small Reverse Shoulder System is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2018-07-25 under approval number K180632. 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 Exactech Equinoxe Small Reverse Shoulder System?

Exactech Equinoxe Small Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2018-07-25. It is manufactured by Exactech, Inc.. The 510(k) number is K180632.

When was Exactech Equinoxe Small Reverse Shoulder System approved by the FDA?

Exactech Equinoxe Small Reverse Shoulder System received FDA 510(k) clearance on 2018-07-25, under approval number K180632.

What company makes Exactech Equinoxe Small Reverse Shoulder System?

Exactech Equinoxe Small Reverse Shoulder System is manufactured by Exactech, Inc..

What is the FDA product code for Exactech Equinoxe Small Reverse Shoulder System?

The FDA product code for Exactech Equinoxe Small Reverse Shoulder System is PHX.

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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) PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Exactech, Inc.

K153649Exactech® Novation® Element Press-fit Femoral Stem K160697Gibralt® Spine System and Gibralt® Occipital Spine System K153595Optetrak Logic Metaphyseal Cones K160484Optetrak Advanced Patella K152217Exactech Vantage Total Ankle System K153776Optetrak One Logic Femoral Components

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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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