BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alcantara™ Thoracolumbar Plating

    DI: B030TLP434WR0 · Model: TLP-434WR · CAMBER SPINE TECHNOLOGIES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Alcantara™ Thoracolumbar Plating
    Primary DI
    B030TLP434WR0
    Version / Model
    TLP-434WR
    Company Name
    CAMBER SPINE TECHNOLOGIES, LLC
    Labeler DUNS
    054205979
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-01
    Public Version
    2
    Public Version Date
    2025-11-20
    Public Version Status
    Update
    Public Device Record Key
    1324a85b-2687-4d39-a7d1-42bcd00cbf6a

    Device Description

    4-Hole Right Windswept Sacral Plate, 47mm

    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
    No
    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
    46653 Spinal fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary B030TLP434WR0

    Customer Contacts

    Phone
    +1 (484) 427-7060
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K232256 000