Name: Predicase
Price: 199 USD

K-number	K233542
Device name	Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
Applicant	Stryker Leibinger GmbH & Co KG
Product code	OLO
Device class	Class II
Decision date	Mar 14, 2024
Decision	Substantially Equivalent
Regulation	882.4560

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

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

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