BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    OSTEOTEC LIMITED

    Reg #: 3008395366 · FEI: 3008395366 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    OSTEOTEC LIMITED
    Registration Number
    3008395366
    FEI Number
    3008395366
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 81, Greenham Business Park
    City
    Newbury West Berkshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K140453

    Owner / Operator

    Firm Name
    Osteotec Limited
    Operator Number
    10032513
    Address
    Building 81, Greenham Business Park
    City
    Newbury
    State
    GB-NOTA
    Postal Code
    RG19 6HW
    Country
    GB
    Correspondent
    Edna C Kurokawa

    US Agent

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

    Products

    Device Name Product Code
    Prosthesis, Finger, Constrained, Polymer KYJ
    Crimper, Pin HXQ
    Broach HTQ
    Orthopedic Manual Surgical Instrument LXH
    Template HWT
    Orthopedic Tray OJH
    Awl HWJ
    Tray, Surgical, Instrument FSM

    Proprietary Names

    Osteotec Silicone Finger Implant Chiroklip Osteotec Silicone Finger Rasp CBG Osteotec SFI Instruments Osteotec Silicone Finger Sizer Osteotec SFI Sizers Osteotec Silicone Finger All In One Instrument tray, empty Osteotec Silicone Finger Awl Osteotec Silicone Finger All In One Instrument tray

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility