BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vertebrex Kyphoplasty Catheter (Flex)/Kit; Vertebrex Kyphoplasty Catheter (Micro)/Kit; Vertebrex Kyphoplasty Catheter (Mini)/Kit;

    Reg #: 3008583793 · FEI: 3008583793 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ZAVATION
    Registration Number
    3008583793
    FEI Number
    3008583793
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3670 Flowood Dr
    City
    Flowood
    State
    MS
    ZIP
    39232
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132620

    Owner / Operator

    Firm Name
    Zavation Medical Products LLC
    Operator Number
    10055475
    Address
    3670 Flowood Dr
    City
    Flowood
    State
    MS
    Postal Code
    39232
    Country
    US
    Correspondent
    Elke Carter

    Products

    Device Name Product Code
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN

    Proprietary Names

    Vertebrex Kyphoplasty Catheter (Flex)/Kit; Vertebrex Kyphoplasty Catheter (Micro)/Kit; Vertebrex Kyphoplasty Catheter (Mini)/Kit; 11G Renova Spine Balloon Catheter/Kit; InterV Kyphoplasty Catheter (Flex)/Kit; Vertebrex Kyphoplasty Catheter/Kit; ZV Plasty Kyphoplasty Catheter InterV Kyphoplasty Catheter (Micro)/Kit; InterV Kyphoplasty Catheter (Mini)/Kit; InterV Kyphoplasty Catheter/Kit; ZV Plasty Kyphoplasty Catheter (Mini)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device