Name: Predicase
Price: 199 USD

K-number	DEN200064
Device name	Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
Applicant	Canary Medical, Inc.
Product code	QPP
Device class	Class II
Decision date	Aug 27, 2021
Decision	Not 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 with Canary Health Implanted Reporting Processor (CHIRP) System

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