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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 the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) 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. The listed applicant is Exactech, Inc.. The 510(k) number is K243448.

When did Equinoxe® Shoulder System receive FDA 510(k) clearance?

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

Who is the listed applicant for Equinoxe® Shoulder System?

The FDA 510(k) record lists Exactech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Exactech, 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.

K260583Equinoxe® Shoulder SystemK250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsK243275Equinoxe® Scapula Fracture SystemK243839Alteon® HA Femoral StemsK240393Exactech® TRULIANT® Knee SystemK233482Equinoxe® Central Screw Baseplate 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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