BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DRIVER 9734315 VIOLET ASSY

    Reg #: 3007137928 · FEI: 3007137928 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    54
    Establishment Types
    1
    Classifications
    1

    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
    K124004

    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
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    DRIVER 9734315 VIOLET ASSY TAP 9735048 SOLERA ILIAC 7.5 TRACKER 9734734 NAVLOCK UNIV GREEN TAP 9734707 SOLERA NONCANN 5.5 TAP 9735049 8.5 SOLERA ILIAC TAP 9734708 SOLERA NONCANN 6 TAP 9734240 6.5 TAP 9735051 SOLERA ILIAC 10.5 TAP 9734296 3.75 TAP 9734705 SOLERA NONCANN 4.5 SCREWDRIVER 9734278 LEGACY PEEK STD TAP 9734304 8.5 TAP 9734722 LEGACY NONCAN 6.5 TAP 9734297 4 TAP 9734300 5.5 AWL 9734404 TIP TAP 9734282 4-4.5 AWL TIP AWL SHARP 9734678 NAVLOCK TAP 9734298 4.5 PROBE 9734402 LUMBAR TAP 9734718 LEGACY NONCAN 4.5 TRACKER 9734683 NAVLOCK UNIV ORANGE TAP 9734285 6.5-7.5 AWL TIP TAP 9734299 5 SCREWDRIVER 9734275 LGY G4 REDUCTIN SCREWDRIVER 9734374 LEGACY PEEK STD DRIVER 9735023 SOLERA 5.5/6 MAS DRIVER 9734259 ORANGE ASSY TAP 9734284 5.5-6.5 AWL TIP PROBE 9734403 THORACIC TAP 9734239 5.5 TAP 9734301 6 TAP 9734711 SOLERA NONCANN 8.5 TAP 9734302 6.5 TRACKER 9734682 NAVLOCK UNIV VIOLET TAP 9735047 SOLERA ILIAC 6.5 DRIVER 9735027 SOLERA 5.5/6 FAS/S TAP 9734720 LEGACY NONCAN 5.5 THORACIC PROBE 9734680 NAVLOCK TAP 9734283 4.5-5.5 AWL TIP SCREWDRIVER 9734857 SOLERA RDN MAST DRIVER 9735024 SOLERA 5.5/6 MAS SCREWDRIVER 9734274 LGY G4 STANDARD DRIVER 9735025 SOLERA 5.5/6 RMAS TAP 9734709 SOLERA NONCANN 6.5 TAP 9734706 SOLERA NONCANN 5 TAP 9734710 SOLERA NONCANN 7.5 TAP 9734303 7.5 DRIVER 9735026 SOLERA 5.5/6 RMAS TRACKER 9734590 NAVLOCK UNIV GREY TAP 9735050 SOLERA ILIAC 9.5 LUMBAR PROBE 9734679 NAVLOCK TAP 9734238 4.5 DRIVER 9734228 GRAY ASSY

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)