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FDA 510(k)

ToeJack MIS Bunion System

K-Number: K253423 · 2025-11-18

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2025-11-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ToeJack MIS Bunion System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2025-11-18 under approval number K253423. 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 ToeJack MIS Bunion System?

ToeJack MIS Bunion System is a medical device that received FDA 510(k) clearance on 2025-11-18. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K253423.

When was ToeJack MIS Bunion System approved by the FDA?

ToeJack MIS Bunion System received FDA 510(k) clearance on 2025-11-18, under approval number K253423.

What company makes ToeJack MIS Bunion System?

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

What is the FDA product code for ToeJack MIS Bunion System?

The FDA product code for ToeJack 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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