BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PANTERA®- Proximal Humerus Fracture Fixation Plate System

    Reg #: 3008747271 · FEI: 3008747271 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TOBY ORTHOPAEDICS
    Registration Number
    3008747271
    FEI Number
    3008747271
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6355 SW 8th Street, Suite 101
    City
    Miami
    State
    FL
    ZIP
    33144
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081608

    Owner / Operator

    Firm Name
    Toby Orthopaedics
    Operator Number
    10028539
    Address
    6355 SW 8TH STREET, SUITE 101
    City
    Miami
    State
    FL
    Postal Code
    33144
    Country
    US
    Correspondent
    Eduardo Gonzalez-Hernandez

    Products

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

    Proprietary Names

    PANTERA®- Proximal Humerus Fracture Fixation Plate System

    Establishment Types

    Manufacture Medical Device