K-number	K241359
Device name	Medline UNITE® MIS Foot Recon Screw System
Applicant	Medline Industries, LP
Product code	HWC
Device class	Class II
Decision date	Aug 2, 2024
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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Medline UNITE® MIS Foot Recon Screw System

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