BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    OSARTIS GMBH

    Reg #: 9615014 · FEI: 3005568854 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    13
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    OSARTIS GMBH
    Registration Number
    9615014
    FEI Number
    3005568854
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Auf der Beune 101
    City
    Muenster Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K210125

    Owner / Operator

    Firm Name
    OSARTIS GmbH
    Operator Number
    10055041
    Address
    Auf der Beune 101
    City
    Muenster
    State
    Hesse
    Postal Code
    64839
    Country
    DE
    Correspondent
    Volker Stirnal

    US Agent

    Business Name
    Brauer Device Consultants, LLC
    Contact Name
    Christine L. Brauer
    Address
    33651 Summer Walk Unit 22004
    City
    Bethany Beach
    State
    DE
    ZIP
    19930
    Country
    US
    Email
    [email protected]
    Phone
    301 5451990

    Products

    Device Name Product Code
    Bone Cement LOD
    Bone Cement, Antibiotic MBB
    Cement, Bone, Vertebroplasty NDN
    Bone Cement, Posterior Screw Augmentation PML
    Thoracolumbosacral Pedicle Screw System NKB
    Dressing, Wound, Drug FRO
    Mixer, Cement, For Clinical Use JDZ
    Evacuator, Vapor, Cement Monomer JDY
    Dispenser, Cement KIH

    Proprietary Names

    BonOs HV Genta Versabond BonOs Inject BonOs R Genta Vertecem II Mixing Kit BIOWASH Surgical Irrigation XPERIENCE Advanced Surgical Irrigation MixOR BonOs R BonOs HV BLASTX Wound Gel Traumacem V+ Injectable Bone Cement Versabond AB

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility