Name: Predicase
Price: 199 USD

K-number	K223767
Device name	Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
Applicant	Stryker Leibinger GmbH & Co KG
Product code	OLO
Device class	Class II
Decision date	Feb 13, 2023
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System

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