Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Exactech® Equinoxe® Preserve Stem

K-Number: K162726 · 2017-02-01

ApplicantExactech, Inc.
Decision Date2017-02-01
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Equinoxe® Preserve Stem is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2017-02-01 under approval number K162726. 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® Preserve Stem?

Exactech® Equinoxe® Preserve Stem is a medical device that received FDA 510(k) clearance on 2017-02-01. It is manufactured by Exactech, Inc.. The 510(k) number is K162726.

When was Exactech® Equinoxe® Preserve Stem approved by the FDA?

Exactech® Equinoxe® Preserve Stem received FDA 510(k) clearance on 2017-02-01, under approval number K162726.

What company makes Exactech® Equinoxe® Preserve Stem?

Exactech® Equinoxe® Preserve Stem is manufactured by Exactech, Inc..

What is the FDA product code for Exactech® Equinoxe® Preserve Stem?

The FDA product code for Exactech® Equinoxe® Preserve Stem is PHX.

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

View all 41 devices →

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.

↑