K-number	K242603
Device name	MyPAO SA guides
Applicant	Medacta International S.A.
Product code	PBF
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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MyPAO SA guides

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