Name: Predicase
Price: 199 USD

K-number	K252106
Device name	External Fixation Mini Rail System
Applicant	Paragon 28, Inc.
Product code	KTT
Device class	Class II
Decision date	Sep 30, 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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External Fixation Mini Rail System

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