K-number	K230876
Device name	RI.KNEE Adjustable Tibia Cut Guide
Applicant	Enztec Limited
Product code	OLO
Device class	Class II
Decision date	Jun 27, 2023
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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RI.KNEE Adjustable Tibia Cut Guide

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