Name: Predicase
Price: 199 USD

K-number	K251441
Device name	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
Applicant	Inion OY
Product code	JEY
Device class	Class II
Decision date	Nov 7, 2025
Decision	Substantially Equivalent
Regulation	872.4760

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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Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

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