BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pantheon PFR System

    DI: 08050880237975 · Model: Compression Screw · ADLER ORTHO SPA
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pantheon PFR System
    Primary DI
    08050880237975
    Version / Model
    Compression Screw
    Catalog Number
    0200770
    Company Name
    ADLER ORTHO SPA
    Labeler DUNS
    338847291
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-03
    Public Version
    2
    Public Version Date
    2025-06-09
    Public Version Status
    Update
    Public Device Record Key
    02299627-0680-4580-9170-47e1a306b6cf

    Device Description

    Pantheon Salvage Plate with Spikes Compression Screw (Long)

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
    MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

    GMDN Terms

    Code Name
    63998 Implantable orthopaedic/craniofacial device connection screw

    Identifiers

    Type ID
    Primary 08050880237975