BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Artikon.malleo System-Foot Stirrup, lamination technology, size 16 or size 20

    Reg #: 8010401 · FEI: 5812 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STREIFENEDER ortho.production gmbH
    Registration Number
    8010401
    FEI Number
    5812
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MOOSFELDSTRASSE 10
    City
    EMMERING Bavaria
    Country
    DE

    Owner / Operator

    Firm Name
    Streifeneder ortho.production GmbH
    Operator Number
    8010401
    Address
    MOOSFELDSTRASSE 10, --
    City
    EMMERING, BAVARIA
    State
    DE-BY
    Postal Code
    82275
    Country
    DE

    US Agent

    Business Name
    Fabtech Systems LLC.
    Contact Name
    Greg Mattson
    Address
    3304 Hill Avenue
    City
    Everett
    State
    WA
    ZIP
    98201
    Country
    US
    Email
    [email protected]
    Phone
    425 3499557

    Products

    Device Name Product Code
    Joint, Ankle, External Brace ITW

    Proprietary Names

    Artikon.malleo System-Foot Stirrup, lamination technology, size 16 or size 20 Artikon.malleo System-Ankle Joint Set without spring, size 16 or size 20 Artikon.malleo System-Ankle Joint Set with spring, size 16 or size 20 Artikon.malleo System-Foot Stirrup, rivet technology, size 16 or size 20 Transtibial Prosthetic Leg Splint, centered joint head AchilloMax, Achilles Tendon Support with silicone pads, including slide-on assistant

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device