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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 the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2021-11-24 under 510(k) 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. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K211650.

When did The Radian MIS Bunion System receive FDA 510(k) clearance?

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

Who is the listed applicant for The Radian MIS Bunion System?

The FDA 510(k) record lists Nvision Biomedical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Nvision Biomedical Technologies, Inc. as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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