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FDA 510(k)

restor3d Kinos Axiom Total Ankle System

K-Number: K240591 · 2024-04-29

ApplicantRestor3D, Inc.
Decision Date2024-04-29
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

restor3d Kinos Axiom Total Ankle System is a medical device manufactured by Restor3D, Inc.. It received FDA 510(k) clearance on 2024-04-29 under approval number K240591. 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 restor3d Kinos Axiom Total Ankle System?

restor3d Kinos Axiom Total Ankle System is a medical device that received FDA 510(k) clearance on 2024-04-29. It is manufactured by Restor3D, Inc.. The 510(k) number is K240591.

When was restor3d Kinos Axiom Total Ankle System approved by the FDA?

restor3d Kinos Axiom Total Ankle System received FDA 510(k) clearance on 2024-04-29, under approval number K240591.

What company makes restor3d Kinos Axiom Total Ankle System?

restor3d Kinos Axiom Total Ankle System is manufactured by Restor3D, Inc..

What is the FDA product code for restor3d Kinos Axiom Total Ankle System?

The FDA product code for restor3d 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, Inc.

K201314Restor3d Utility Wedge K201393restor3d MTP Implant K252067Velora Acetabular System K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System K242356TIDAL Fusion Cage System

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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