BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TopLock

    DI: 00840124511644 · Model: TP-KL-1000-S · FUSION ORTHOPEDICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    TopLock
    Primary DI
    00840124511644
    Version / Model
    TP-KL-1000-S
    Company Name
    FUSION ORTHOPEDICS, LLC
    Labeler DUNS
    080307067
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-29
    Public Version
    1
    Public Version Date
    2024-05-07
    Public Version Status
    New
    Public Device Record Key
    88f4783b-8875-4837-9016-cbd3ccfc54b6

    Device Description

    3.5mm Knotless Anchor Implant Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

    GMDN Terms

    Code Name
    45062 Tendon/ligament bone anchor, non-bioabsorbable

    Identifiers

    Type ID
    Primary 00840124511644