BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TOBY ORTHOPAEDICS

    Reg #: 3008747271 · FEI: 3008747271 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    TOBY ORTHOPAEDICS
    Registration Number
    3008747271
    FEI Number
    3008747271
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6355 SW 8th Street, Suite 101
    City
    Miami
    State
    FL
    ZIP
    33144
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131834

    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
    Retractor GAD
    Tray, Surgical, Instrument FSM
    Retainer, Surgical GCZ
    Guide, Surgical, Instrument FZX
    Gauge, Depth HTJ
    Bit, Drill HTW
    Tray, Surgical LRP
    Screwdriver HXX
    Plate, Fixation, Bone HRS
    Passer HWQ
    Screw, Fixation, Bone HWC

    Proprietary Names

    Flexor Tendon Sheath Retractor TOBY- Sterilization Tray TOBY- SURGICAL RETAINER TOBY- Surgical Guides TOBY- Depth Gauge TOBY- Drill Bits TOBY- Surgical Instruments Tray TOBY- Drivers WOLF®- Long Bone Plate System Flexor Tendon Suture Retriever/ Sheath Dilator PANTERA®- Proximal Humerus Fracture Fixation Plate System

    Establishment Types

    Manufacture Medical Device