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FDA 510(k)

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

K-Number: K220413 · 2022-06-22

ApplicantCanary Medical USA, LLC
Decision Date2022-06-22
Product CodeQPP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is a medical device manufactured by Canary Medical USA, LLC. It received FDA 510(k) clearance on 2022-06-22 under approval number K220413. The device is classified under product code QPP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is a medical device that received FDA 510(k) clearance on 2022-06-22. It is manufactured by Canary Medical USA, LLC. The 510(k) number is K220413.

When was Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System approved by the FDA?

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System received FDA 510(k) clearance on 2022-06-22, under approval number K220413.

What company makes Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is manufactured by Canary Medical USA, LLC.

What is the FDA product code for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

The FDA product code for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is QPP.

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 42180407 Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities. Frontiers in drug safety and regulation (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Canary Medical USA, LLC

K223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System K234056canturio® se (Canturio Smart Extension)

Related Devices (Code: QPP)

DEN200064Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical, Inc. K223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLC K234056canturio® se (Canturio Smart Extension)Canary Medical USA, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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