BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Sub-Talar Lok

    DI: 10815375021096 · Model: ST5010 · Restore Surgical LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sub-Talar Lok
    Primary DI
    10815375021096
    Version / Model
    ST5010
    Company Name
    Restore Surgical LLC
    Labeler DUNS
    792932626
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-17
    Public Version
    4
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    ab91b8c9-dde9-4eb5-95cb-04fc540ba141
    Distribution End Date
    2017-12-29

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HWC Screw, Fixation, Bone

    GMDN Terms

    Code Name
    40352 Subtalar implant, non-bioabsorbable

    Identifiers

    Type ID
    Primary 10815375021096