BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Polyaxial Reduction Screw, 6.5 x 40

    DI: M73924166540 · Model: 2416-6540 · CAPTIVA SPINE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Polyaxial Reduction Screw, 6.5 x 40
    Primary DI
    M73924166540
    Version / Model
    2416-6540
    Company Name
    CAPTIVA SPINE, INC.
    Labeler DUNS
    836975784
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-30
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    2436c570-6d6f-458d-9ed0-0fbee7b69d5b
    Distribution End Date
    2017-07-28

    Device Description

    Polyaxial Reduction Screw, 6.5 x 40

    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
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    MNI Orthosis, Spinal Pedicle Fixation
    MNH Orthosis, Spondylolisthesis Spinal Fixation

    GMDN Terms

    Code Name
    61325 Bone-screw internal spinal fixation system, non-sterile

    Identifiers

    Type ID
    Primary M73924166540

    Premarket Submissions

    Submission Number Supplement Number
    K120292 000