Name: Predicase
Price: 199 USD

K-number	K252661
Device name	SternaFuse Ti Fixation System
Applicant	Fusion Innovations, LLC
Product code	HRS
Device class	Class II
Decision date	Nov 19, 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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SternaFuse Ti Fixation System

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