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FDA 510(k)

Kinos Total Ankle System

K-Number: K242868 · 2024-10-18

ApplicantRestor3D
Decision Date2024-10-18
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kinos Total Ankle System is a medical device manufactured by Restor3D. It received FDA 510(k) clearance on 2024-10-18 under approval number K242868. 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 Total Ankle System?

Kinos Total Ankle System is a medical device that received FDA 510(k) clearance on 2024-10-18. It is manufactured by Restor3D. The 510(k) number is K242868.

When was Kinos Total Ankle System approved by the FDA?

Kinos Total Ankle System received FDA 510(k) clearance on 2024-10-18, under approval number K242868.

What company makes Kinos Total Ankle System?

Kinos Total Ankle System is manufactured by Restor3D.

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

The FDA product code for Kinos 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

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Related Devices (Code: HSN)

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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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