Name: Predicase
Price: 199 USD

K-number	K232154
Device name	MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
Applicant	MiRus, LLC
Product code	OVD
Device class	Class II
Decision date	Sep 11, 2023
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

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