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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 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 2025-11-18 under 510(k) 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. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K253423.

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

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

Who is the listed applicant for ToeJack 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 ToeJack MIS Bunion System?

The FDA product code for ToeJack 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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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