Name: Predicase
Price: 199 USD

K-number	K253423
Device name	ToeJack MIS Bunion System
Applicant	Nvision Biomedical Technologies, Inc.
Product code	HRS
Device class	Class II
Decision date	Nov 18, 2025
Decision	Substantially Equivalent
Regulation	888.3030

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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ToeJack MIS Bunion System

Everything you need for a 510(k) submission. Nothing you don't.