BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    VersaTi™ 4mm Suture Anchor

    Reg #: 3024856795 · FEI: 3024856795 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTHO-DESIGN
    Registration Number
    3024856795
    FEI Number
    3024856795
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17 Dely Road, Hazelwood
    City
    Pretoria Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K212381

    Owner / Operator

    Firm Name
    Ortho-Design
    Operator Number
    10086235
    Address
    17 Dely Street
    City
    Pretoria
    State
    Gauteng
    Postal Code
    0181
    Country
    ZA
    Correspondent
    Dian Peach

    US Agent

    Business Name
    TriMed Inc.
    Contact Name
    David Medoff
    Address
    27533 Avenue Hopkins, 3
    City
    Santa Clarita
    State
    CA
    ZIP
    91355
    Country
    US
    Email
    [email protected]
    Phone
    661 2557406

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    VersaTi™ 4mm Suture Anchor VersaTi™ 3mm Suture Anchor VersaLat™ PEEK 7.5mm Suture Anchor DueLock PEEK 2.9mm Suture Anchor VersaTi™ 5.5mm Suture Anchor Threaded Ti-PEEK, 6.5x17mm, 2 Suture, Needles Threaded PEEK, 5.5x15mm, 2 Suture, Needles MiniTi™ 2mm Suture Anchor Impact PEEK 2.9x10mm, 1 Suture Threaded Ti 4x13mm, 2 Suture, Needles Threaded Ti-PEEK, 6.5x17mm, 1 Suture 1 Tape Threaded Ti-PEEK, 6.5x17mm, 2 Suture Threaded Ti 3x11mm, 2 Suture, Needles Threaded Ti-PEEK, 6.5x17mm, 2 Tape VersaTap™ 6mm Suture Anchor VersaLat™ PEEK 5.5mm Suture Anchor Threaded Ti 6x17mm, 2 Suture, Needles Threaded Ti 2x6mm, 2 Suture, Needles, Drill VersaLat™ PEEK 6.5mm Suture Anchor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility