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FDA 510(k)

Genius / Genuin Total Knee System

K-Number: K200765 · 2021-05-05

ApplicantBiorad Medisys Pvt, Ltd.
Decision Date2021-05-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genius / Genuin Total Knee System is a medical device manufactured by Biorad Medisys Pvt, Ltd.. It received FDA 510(k) clearance on 2021-05-05 under approval number K200765. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genius / Genuin Total Knee System?

Genius / Genuin Total Knee System is a medical device that received FDA 510(k) clearance on 2021-05-05. It is manufactured by Biorad Medisys Pvt, Ltd.. The 510(k) number is K200765.

When was Genius / Genuin Total Knee System approved by the FDA?

Genius / Genuin Total Knee System received FDA 510(k) clearance on 2021-05-05, under approval number K200765.

What company makes Genius / Genuin Total Knee System?

Genius / Genuin Total Knee System is manufactured by Biorad Medisys Pvt, Ltd..

What is the FDA product code for Genius / Genuin Total Knee System?

The FDA product code for Genius / Genuin Total Knee System is JWH.

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)

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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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