K-number	K211512
Device name	VISIONAIRE UK Patient Matched Cutting Guides
Applicant	Smith & Nephew, Inc.
Product code	HSX
Device class	Class II
Decision date	Sep 16, 2021
Decision	Substantially Equivalent
Regulation	888.3520

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Source

View the full FDA submission: accessdata.fda.gov

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VISIONAIRE UK Patient Matched Cutting Guides

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