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FDA 510(k)

Kinos Axiom Total Ankle System

K-Number: K232595 · 2023-11-28

ApplicantRestor3D
Decision Date2023-11-28
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kinos Axiom Total Ankle System is a medical device manufactured by Restor3D. It received FDA 510(k) clearance on 2023-11-28 under approval number K232595. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kinos Axiom Total Ankle System?

Kinos Axiom Total Ankle System is a medical device that received FDA 510(k) clearance on 2023-11-28. It is manufactured by Restor3D. The 510(k) number is K232595.

When was Kinos Axiom Total Ankle System approved by the FDA?

Kinos Axiom Total Ankle System received FDA 510(k) clearance on 2023-11-28, under approval number K232595.

What company makes Kinos Axiom Total Ankle System?

Kinos Axiom Total Ankle System is manufactured by Restor3D.

What is the FDA product code for Kinos Axiom Total Ankle System?

The FDA product code for Kinos Axiom Total Ankle System is HSN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Restor3D

K193491restor3d Metallic Interference Screw K220523restor3d TiDAL Lumbar Interbody Fusion Device K211789restor3d Pin Implants K231458Extremity Staple K223326Axiom PSR System K242868Kinos Total Ankle System

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Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc

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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