BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Pedicle marker

    Reg #: 3017155536 · FEI: 3017155536 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SK PHARMA LOGISTICS GMBH
    Registration Number
    3017155536
    FEI Number
    3017155536
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Remusweg 8
    City
    Bielefeld North Rhine-Westphalia
    Country
    DE

    Owner / Operator

    Firm Name
    SK Pharma Logistics GmbH
    Operator Number
    10091163
    Address
    Remusweg 8
    City
    Bielefeld
    State
    North Rhine-Westphalia
    Postal Code
    33729
    Country
    DE
    Correspondent
    Lars Wiese

    US Agent

    Business Name
    confinis USA Inc.
    Contact Name
    Alfred Lerch
    Address
    600 Park Offices Drive Suite 300, Unit #50
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    910 2289391

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Pedicle marker Posterior instrument kit Persuader Cage puller Cage Bent Curette Kit Revision Guide Pedicle Screw Instrument Kit T-Handle Kit Ratchet T-Handle - 1/4", NS Non-constraint torque limiter (10x) Cage straight curette kit Non-constraint torque limiter Single Use Pedicle marker (2x) Marker Base (10x1) Scraper / distractor Compressor Distractor Kit Screw Guide Remover Cage Pusher Kit Revision Guide (10x1) K-wire Kit Removal Kit Cage holder Cage Instrument Kit

    Establishment Types

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