BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anteralign Spinal System with Titan nanoLock Surface technology

    DI: 00763000508814 · Model: 4675040 · MEDTRONIC SOFAMOR DANEK, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anteralign Spinal System with Titan nanoLock Surface technology
    Primary DI
    00763000508814
    Version / Model
    4675040
    Company Name
    MEDTRONIC SOFAMOR DANEK, INC.
    Labeler DUNS
    830350380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-21
    Public Version
    2
    Public Version Date
    2023-01-19
    Public Version Status
    Update
    Public Device Record Key
    e19d8d52-2537-41a1-8857-0d47bdc0460b

    Device Description

    BONE SCREW 4675040 LS 5.0X40MM

    Device Characteristics

    Single Use
    Yes
    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MAX Intervertebral fusion device with bone graft, lumbar
    OVD Intervertebral fusion device with integrated fixation, lumbar

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00763000508814

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K212524 000