Name: Predicase
Price: 199 USD

K-number	K220413
Device name	Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Applicant	Canary Medical USA, LLC
Product code	QPP
Device class	Class II
Decision date	Jun 22, 2022
Decision	Substantially Equivalent
Regulation	888.3600

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Source

View the full FDA submission: accessdata.fda.gov

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Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

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