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)

Equinoxe® Central Screw Baseplate System

K-Number: K233482 · 2024-07-18

ApplicantExactech, Inc.
Decision Date2024-07-18
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Equinoxe® Central Screw Baseplate System is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2024-07-18 under approval number K233482. 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® Central Screw Baseplate System?

Equinoxe® Central Screw Baseplate System is a medical device that received FDA 510(k) clearance on 2024-07-18. It is manufactured by Exactech, Inc.. The 510(k) number is K233482.

When was Equinoxe® Central Screw Baseplate System approved by the FDA?

Equinoxe® Central Screw Baseplate System received FDA 510(k) clearance on 2024-07-18, under approval number K233482.

What company makes Equinoxe® Central Screw Baseplate System?

Equinoxe® Central Screw Baseplate System is manufactured by Exactech, Inc..

What is the FDA product code for Equinoxe® Central Screw Baseplate System?

The FDA product code for Equinoxe® Central Screw Baseplate System is PHX.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT04786821 Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis COMPLETED NCT07593807 TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis ACTIVE_NOT_RECRUITING NCT07587593 The IVCare Adaptive Platform Trial NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

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.

↑