BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASSY,TRIAL, CLYDESDALE, 14 X 50MM

    Reg #: 3007137928 · FEI: 3007137928 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Tecomet Boulder
    Registration Number
    3007137928
    FEI Number
    3007137928
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6265 Gunbarrel Ave Suite A
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131425

    Owner / Operator

    Firm Name
    Tecomet, Inc.
    Operator Number
    10042631
    Address
    170 New Boston Street
    City
    Woburn
    State
    MA
    Postal Code
    01801
    Country
    US

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    ASSY,TRIAL, CLYDESDALE, 14 X 50MM ASSY,TRIAL, CLYDESDALE, 10 X 50MM ASSY,TRIAL, CLYDESDALE, 12 X 55MM ASSY,TRIAL, CLYDESDALE, 12 X 45MM ASSY,TRIAL, CLYDESDALE, 12 X 50MM ASSY,TRIAL, CLYDESDALE, 10 X 45MM ASSY,TRIAL, CLYDESDALE, 8 X 55MM ASSY,TRIAL, CLYDESDALE, 14 X 55MM FRAME 9735249 STEALTHAIR SPINE ASSY,TRIAL, CLYDESDALE, 8 X 50MM ASSY,TRIAL, CLYDESDALE, 14 X 45MM ASSY,TRIAL, CLYDESDALE, 8 X 45MM ASSY,TRIAL, CLYDESDALE, 10 X 55MM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)