Name: Predicase
Price: 199 USD

K-number	K191906
Device name	MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
Applicant	MiRus, LLC
Product code	MAX
Device class	Class II
Decision date	May 18, 2020
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF

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