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FDA 510(k)

INFINITY Total Ankle System, INBONE Total Ankle System

K-Number: K191393 · 2019-08-22

ApplicantWrightmedicaltechnologyinc
Decision Date2019-08-22
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INFINITY Total Ankle System, INBONE Total Ankle System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-08-22 under approval number K191393. 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 INFINITY Total Ankle System, INBONE Total Ankle System?

INFINITY Total Ankle System, INBONE Total Ankle System is a medical device that received FDA 510(k) clearance on 2019-08-22. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K191393.

When was INFINITY Total Ankle System, INBONE Total Ankle System approved by the FDA?

INFINITY Total Ankle System, INBONE Total Ankle System received FDA 510(k) clearance on 2019-08-22, under approval number K191393.

What company makes INFINITY Total Ankle System, INBONE Total Ankle System?

INFINITY Total Ankle System, INBONE Total Ankle System is manufactured by Wrightmedicaltechnologyinc.

What is the FDA product code for INFINITY Total Ankle System, INBONE Total Ankle System?

The FDA product code for INFINITY Total Ankle System, INBONE Total Ankle System is HSN.

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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 Wrightmedicaltechnologyinc

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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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