BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    P.A.C.E.

    DI: 04251944144596 · Model: M211117-307 · MAXXOS - Medical GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    P.A.C.E.
    Primary DI
    04251944144596
    Version / Model
    M211117-307
    Company Name
    MAXXOS - Medical GmbH
    Labeler DUNS
    313262497
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-13
    Public Version
    1
    Public Version Date
    2025-12-22
    Public Version Status
    New
    Public Device Record Key
    2bd848f1-ac77-4c29-8d7d-d67637d03b8d

    Device Description

    P.A.C.E. MTP Fusion Plate, comp. 10°, Long, Left

    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
    MR Conditional
    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
    HRS Plate, Fixation, Bone

    GMDN Terms

    Code Name
    46647 Orthopaedic fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 04251944144596

    Premarket Submissions

    Submission Number Supplement Number
    K251892 000