BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CANARY MEDICAL USA LLC

    Reg #: 3015802419 · FEI: 3015802419 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    27
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    CANARY MEDICAL USA LLC
    Registration Number
    3015802419
    FEI Number
    3015802419
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2710 Loker Ave. West, Suite 350
    City
    Carlsbad
    State
    CA
    ZIP
    92010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234056

    Owner / Operator

    Firm Name
    Canary Medical, Inc.
    Operator Number
    10082445
    Address
    2090 - 1055 West Georgia St.
    City
    Vancouver
    State
    British Columbia
    Postal Code
    V6E 3R5
    Country
    CA
    Correspondent
    Nora York

    Products

    Device Name Product Code
    Goniometer, Nonpowered KQW
    Implantable Post-Surgical Kinematic Measurement Knee Device QPP
    Medical Device Data System OUG
    Goniometer, Ac-Powered KQX

    Proprietary Names

    Canary Medical Gait Parameters Canturio® Smart Extension 14mm (D) x 30mm (H) canturio -te Barcode Scanner canturio - te Home Base Station System canturio - te OR Base Station System canturio - te Laptop Canary Cloud Data Management Platform Home Base Station (Bluetooth) Canary Clinic Laptop Canary Recovery Curves CanarE Clinic Cart CanarE Straps CanarE Charger CanarE canturio - te Modular Bracket Drill Bit canturio - te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. canturio - te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. canturio - te Canary Tibial Ext 14x58mm X-Ray Template canturio te (CTE) with CHIRP System canturio - te Cemented Tibia Drill Bit canturio - te Modular Bracket, Impaction Sleeve canturio - te Provisional canturio - te Modular Bracket Stem Provisional canturio - te Tibia Resection Cutting Guide, Left, 5 Deg. canturio - te Tibia Resection Cutting Guide, Right, 5 Deg. canturio - te Impaction Sleeve Canary Clinical Base Station

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device