BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

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

    K Number: DEN200064 · Decision Aug 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    312

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
    K Number
    DEN200064
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    888.3600
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Applicant
    Canary Medical, Inc.
    Date Received
    October 19, 2020
    Decision Date
    August 27, 2021
    Product Code
    QPP
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QPP Implantable Post-Surgical Kinematic Measurement Knee Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QPP), ordered by most recent decision date.

    canturio® se (Canturio Smart Extension)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

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

    FDA 510(k)
    FDA Class 2 ·Orthopedic

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

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all