K-number	K243715
Device name	Synthes Patient Specific Implants
Applicant	Synthes GmbH
Product code	GXN
Device class	Class II
Decision date	Nov 12, 2025
Decision	Substantially Equivalent
Regulation	882.5330

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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Synthes Patient Specific Implants

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