BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    KINEGEN.stream

    Reg #: 8010401 · FEI: 5812 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    44
    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, Knee, External Limb Component ISY

    Proprietary Names

    KINEGEN.stream KINEGEN.air active KINEGEN.guard Modular Knee Joint with Lock KINEGEN.air Clutch-Lock 201 -Aluminum- KINEGEN.basic Shuttle-Lock 402 -Aluminum- Tube Clamp Adapter Clutch-Lock 401 -Aluminum- Brake Knee Joint with lock Slide Adapter Easy-Lock 303 -Plastic- Polycentric Knee Joint with hydraulic swing phase control Modular Single Axis Knee Joint Clutch-Lock 501 -Aluminum- KINEGEN.smart Modular Knee Joint Easy-Lock 203 -Aluminum- Easy-Lock 403 -Aluminum- Polycentric Knee Joint with pneumatic swing Modular Brake Knee Joint Modular Light Weight Knee Joint Modular Extension Assist Brake Knee Joint with Pneumatic Swing Phase Control Modular 4-Bar Linkage Knee Joint Double Adapter Shuttle-Lock 502 -Aluminum- Socket Attachment Block Shuttle-Lock 152 -Aluminum- Easy-Lock 153 -Aluminum- Connection Adapter Shuttle-Lock 202 -Aluminum- Shuttle-Lock 102 -Plastic- Clutch-Lock 151 -Aluminum- Clutch-Lock 101 -Plastic- Easy-Lock 103 Easy-Lock 503 -Aluminum- Rotation Adapter Socket Adapter Slide.fit - Slip-on aid Shuttle-Lock 302 -Plastic- Clutch-Lock 301 -Plastic- Slip-on aid for knee prostheses

    Establishment Types

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