BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Dakota ALIF Plate System

    DI: 00840019962841 · Model: 69-AS-0817-2C · PRECISION SPINE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dakota ALIF Plate System
    Primary DI
    00840019962841
    Version / Model
    69-AS-0817-2C
    Catalog Number
    69-AS-0817-2C
    Company Name
    PRECISION SPINE, INC.
    Labeler DUNS
    079398589
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-22
    Public Version
    2
    Public Version Date
    2022-07-19
    Public Version Status
    Update
    Public Device Record Key
    2dbb0a1b-ccfd-4e06-bee3-a80fdca34fa9
    Distribution End Date
    2022-07-14

    Device Description

    30X 26 X 17mm X 8° PEEK-2C

    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
    Yes
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

    GMDN Terms

    Code Name
    60762 Polymeric spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00840019962841

    Premarket Submissions

    Submission Number Supplement Number
    K212937 000