BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    LINK MP Monoblock Hip Prosthesis

    Reg #: 3004371426 · FEI: 3003386935 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    5
    Classifications
    1

    Registration Details

    Registration Name
    Waldemar Link GmbH & Co. KG
    Registration Number
    3004371426
    FEI Number
    3003386935
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oststrasse 4-10
    City
    Norderstedt Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K183141

    Owner / Operator

    Firm Name
    WALDEMAR LINK GMBH & CO. KG
    Operator Number
    8010091
    Address
    BARKHAUSENWEG 10, --
    City
    HAMBURG
    State
    DE-NOTA
    Postal Code
    22339
    Country
    DE

    US Agent

    Business Name
    LinkBio Corp.
    Contact Name
    Jennifer Lubrecht
    Address
    69 King Street
    City
    Dover
    State
    NJ
    ZIP
    07801
    Country
    US
    Email
    [email protected]
    Phone
    973 6251333 ext. 119

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    LINK MP Monoblock Hip Prosthesis

    Establishment Types

    Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device