BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DUALX TLIF LOCKOUT SCREW

    DI: B707125300320 · Model: 12530032 · Amplify Surgical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DUALX TLIF LOCKOUT SCREW
    Primary DI
    B707125300320
    Version / Model
    12530032
    Company Name
    Amplify Surgical, Inc.
    Labeler DUNS
    081021000
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-06
    Public Version
    2
    Public Version Date
    2021-05-21
    Public Version Status
    Update
    Public Device Record Key
    b6272c2b-b0e4-45c7-a39c-831a1553be6f

    Device Description

    DUALX TLIF LOCKOUT SCREW

    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
    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
    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

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary B707125300320

    Customer Contacts

    Phone
    7652675439
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K181397 000