BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    ORTHO-DESIGN

    Reg #: 3024856795 · FEI: 3024856795 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    ORTHO-DESIGN
    Registration Number
    3024856795
    FEI Number
    3024856795
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    61 Thomas Edison, Menly Park
    City
    Pretoria Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K212381

    Owner / Operator

    Firm Name
    Ortho-Design
    Operator Number
    10086235
    Address
    61 Thomas Edison Street, Menlo Park
    City
    Pretoria
    State
    Gauteng
    Postal Code
    0081
    Country
    ZA
    Correspondent
    Dian Peach

    US Agent

    Business Name
    Jalex Medical
    Contact Name
    Chhavy Tep-Cullison
    Address
    27865 Clemens Rd
    City
    Westlake
    State
    OH
    ZIP
    44145
    Country
    US
    Email
    [email protected]
    Phone
    440 5410060

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Tap, Bone HWX
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Bit, Drill HTW
    Accessories, Arthroscopic NBH
    Needle, Suturing, Disposable GAB

    Proprietary Names

    OD Drill DoubleTap OD Tap MiniTi VersaTi VersaLat-ST VersaLat VersaTap DueLock VersaTi Drill Nitinol Suture Feeder QuickFire Needle Free Needle VersaLat Ti MicroTi VersaLat 4.75 VersaPEEK

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility