ToeJack MIS Bunion System— 510(k) K253423

Name: FDA 510(k) clearance K253423
Creator: U.S. Food and Drug Administration
Published: 2025-11-18

Substantially Equivalent

Nvision Biomedical Technologies, Inc.

FDA 510(k) clearance K253423 for ToeJack MIS Bunion System, Substantially Equivalent on 2025-11-18. Applicant: Nvision Biomedical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Nvision Biomedical Technologies, Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-09-25
Decision date: 2025-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Nvision Biomedical Technologies, Inc.

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K253718 — enHAnce PEEK Bunion System2026-04-01
K260291 — Vortex5 Tailor's Bunion Correction System2026-03-25
K252657 — Impact PEEK Union Nail System2025-09-19
K250613 — SnapHammer Hammertoe Correction System2025-04-02
K240250 — 3D Printed PEEK Interbody System2024-09-17

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.