BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Hinge Pediatric Plating System

    Reg #: 3000327445 · FEI: 3000327445 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ORTHOPEDIATRICS CANADA ULC
    Registration Number
    3000327445
    FEI Number
    3000327445
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1111 Chomedey Highway (A13)
    City
    Laval Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K090440

    Owner / Operator

    Firm Name
    Pega Medical Inc.
    Operator Number
    10027933
    Address
    1111 Highway 13 Autoroute Chomedey
    City
    Laval
    State
    Quebec
    Postal Code
    H7W 5J8
    Country
    CA
    Correspondent
    Enrique Garcia

    US Agent

    Business Name
    OrthoPediatrics Corp.
    Contact Name
    Ray Garrison
    Address
    2850 Frontier Dr
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US
    Email
    [email protected]
    Phone
    574 2686379

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    Hinge Pediatric Plating System

    Establishment Types

    Manufacture Medical Device