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FDA 510(k)

The Radian MIS Bunion System

K-Number: K211650 · 2021-11-24

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2021-11-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Radian MIS Bunion System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2021-11-24 under approval number K211650. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Radian MIS Bunion System?

The Radian MIS Bunion System is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K211650.

When was The Radian MIS Bunion System approved by the FDA?

The Radian MIS Bunion System received FDA 510(k) clearance on 2021-11-24, under approval number K211650.

What company makes The Radian MIS Bunion System?

The Radian MIS Bunion System is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for The Radian MIS Bunion System?

The FDA product code for The Radian MIS Bunion System is HRS.

Other Devices by Nvision Biomedical Technologies, Inc.

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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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