BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    AMBER IMPLANTS BV

    Reg #: 3043534478 · FEI: 3043534478 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    AMBER IMPLANTS BV
    Registration Number
    3043534478
    FEI Number
    3043534478
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Prinses Beatrixlaan 546, 2595 BM, The Hague
    City
    The Hague Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K250637

    Owner / Operator

    Firm Name
    Amber Implants
    Operator Number
    10094065
    Address
    1660 International Drive, Suite 600
    City
    McLean
    State
    VA
    Postal Code
    22102
    Country
    US
    Correspondent
    Amanda da Silva

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN

    Proprietary Names

    VCFix® spinal system

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device