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Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223803

by Canary Medical Usa Llc

Identifiers

510(k) Number
K223803 FDA 510(k)
FDA Product Code
QPP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3600 FDA 510(k)
Regulation Number
888.3600 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor … by Canary Medical Usa Llc — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

FDA Applicant
Canary Medical USA, LLC

Sources (1)

  • FDA 510(k) K223803 24 fields · synced Jun 18, 2026