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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 the device name listed in this FDA 510(k) record. The listed applicant is Canary Medical USA, LLC. It received FDA 510(k) clearance on 2022-06-22 under 510(k) 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. The listed applicant is Canary Medical USA, LLC. The 510(k) number is K220413.

When did Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System receive FDA 510(k) clearance?

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

Who is the listed applicant for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

The FDA 510(k) record lists Canary Medical USA, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITING

Other records listing Canary Medical USA, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: QPP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234056canturio® se (Canturio Smart Extension)Canary Medical USA, LLCK223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLC

Official Source

View on FDA Database →

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

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