BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

    Reg #: 3008974316 · FEI: 3008974316 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NEOS SURGERY S.L.
    Registration Number
    3008974316
    FEI Number
    3008974316
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parc Tecnològic del Vallès, C/Ceramistes, 2
    City
    Cerdanyola del Vallès Barcelona
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K240137

    Owner / Operator

    Firm Name
    Neos Surgery S.L.
    Operator Number
    10036243
    Address
    P. Mikeletegi, 2, Donostia
    City
    Gipuzkoa
    State
    Guipuzcoa
    Postal Code
    20009
    Country
    ES
    Correspondent
    Eduard Garcia

    US Agent

    Business Name
    Pro Pharma Group
    Contact Name
    Cherita James
    Address
    1129 20th St Nw Ste 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    202 8411075

    Products

    Device Name Product Code
    Cover, Burr Hole GXR

    Proprietary Names

    Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

    Establishment Types

    Manufacture Medical Device