BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LOSPA IS Spinal System

    DI: 08800017284880 · Model: SI.C20.0113 · Corentec Co., Ltd
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LOSPA IS Spinal System
    Primary DI
    08800017284880
    Version / Model
    SI.C20.0113
    Company Name
    Corentec Co., Ltd
    Labeler DUNS
    688739895
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-21
    Public Version
    4
    Public Version Date
    2019-02-07
    Public Version Status
    Update
    Public Device Record Key
    d9c066b2-a3d0-4002-94ad-7ba72b612ee9

    Device Description

    ALIF TRIAL 6° 24 X 30 X 13

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

    GMDN Terms

    Code Name
    44788 Spinal implant trial

    Identifiers

    Type ID
    Primary 08800017284880

    Customer Contacts

    Phone
    +820415857114
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K151408 000