BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SK PHARMA LOGISTICS GMBH

    Reg #: 3017155536 · FEI: 3017155536 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    54
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    SK PHARMA LOGISTICS GMBH
    Registration Number
    3017155536
    FEI Number
    3017155536
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Remusweg 8
    City
    Bielefeld North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K243693

    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
    Retractor GAD
    Dispenser, Cement KIH
    Thoracolumbosacral Pedicle Screw System NKB
    Bone Cement, Posterior Screw Augmentation PML
    Cement, Bone, Vertebroplasty NDN
    Orthopedic Manual Surgical Instrument LXH
    Probe HXB
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Bone Cement LOD
    Screwdriver HXX
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Tap, Bone HWX
    Bender HXW

    Proprietary Names

    Posterior retractor kit 60mm Posterior retractor kit 70mm Posterior retractor kit 50mm Posterior retractor kit 80mm Lateral retractor kit 120mm Lateral retractor kit 140mm Lateral retractor access kit Lateral retractor kit 180mm Lateral retractor kit 160mm Posterior retractor kit 40mm Posterior retractor access kit Cement Pusher Neo Pedicle Screw System Screw Guide Remover Cage Pusher Kit Cage straight curette kit Non-constraint torque limiter Marker Base (10x1) Removal Kit Single Use Pedicle marker (2x) Pedicle marker Revision Guide (10x1) Compressor Distractor Kit Revision Guide Scraper / distractor Cage Bent Curette Kit K-wire Kit Non-constraint torque limiter (10x) Ratchet T-Handle - 1/4", NS Persuader Cage holder Cage Instrument Kit T-Handle Kit Posterior instrument kit Cage puller Pedicle Screw Instrument Kit Steffee Neo Cage System NEO Pedicle Screw System Screwdriver Adaptor - AO, NS Ratchet Handle - 1/4", NS Ratchet Screwdriver ¼”, NS Screwdriver Handle, NS Set-screwdriver (10x1) Ratchet Handle - Hudson, NS Screwdriver Adaptor - 1/4", NS Screwdriver Converter - Hudson, NS Set screwdriver Screwdriver Adaptor - Hudson, NS Screwdriver Converter - AO, NS Screwdriver kit Sterile container Tap kit for Neo Pedicle Screw System Rod Bender NS

    Establishment Types

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