BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    X-ible flexible ankle joints

    Reg #: 9616494 · FEI: 3003117657 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    49
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
    Registration Number
    9616494
    FEI Number
    3003117657
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Max-Naeder-Strasse 15
    City
    DUDERSTADT Lower Saxony
    Country
    DE

    Owner / Operator

    Firm Name
    Ottobock SE & Co. KGaA
    Operator Number
    8010097
    Address
    Max-Naeder-Strasse 15
    City
    Duderstadt
    State
    Lower Saxony
    Postal Code
    37115
    Country
    DE

    US Agent

    Business Name
    Otto Bock HealthCare LP
    Contact Name
    Caleb Beck
    Address
    3820 West Great Lakes Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84120
    Country
    US
    Email
    [email protected]
    Phone
    801 9746647

    Products

    Device Name Product Code
    Joint, Ankle, External Brace ITW

    Proprietary Names

    X-ible flexible ankle joints WalkOn Reaction Plus Fit Kit Malleo Neurexa Multifunctional system ankle joint Active Contour Ankle Joint Unilateral Ankle Joint FitKit WalkOn Lateral Infinity Air Walker, high Foot stirrup Malleo Direxa Stirrup FitKit WalkOn Lateral Junior System-toe Pick-up Ank.Jt. Reaction modul Ankle Support Carbon Ankle Seven WalkOn Flex Fit Kit Malleo Neurexa pro Dual Function Ankle Joint Dyna Ankle - Dynamic Ankle Orthosis Medial joint for correction joint WalkOn Fit Kit WalkOn Reaction lateral FitKit WalkOn Reaction Lateral Malleo Immobil Night Splint Walk-On AFO System Ankle Joint With Lam. Set WalkOn Reaction System-Limit Mot Ankle Jt. Concealed Spring Ankle Joint FitKit WalkOn Flex Junior Achillo Sensa Heel wedges 15 degrees, 30 degrees Infinity Air Walker, low Nexgear side bar bilateral Malleo TriStep Ankle Orthosis Nexgear extension bars Heel wedges 10 degrees, 16 degrees, 22 degrees Malleo Sprint Malleo Sensa Heel Relief Orthosis Des. By Dr. Settner WalkOn Reaction Fit Kit GoOn Walk On Flex WalkOn lateral Nexgear Tango Ankle Joint Nexgear lamination bar bilateral WalkOn Trimable Mulfifunction correction system joints WalkOn Reaction Plus, Junior

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device