BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    My3D® Personalized Pelvic Reconstruction

    DI: B278PVACREC04M0 · Model: PV-ACREC-04M · ONKOS SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    My3D® Personalized Pelvic Reconstruction
    Primary DI
    B278PVACREC04M0
    Version / Model
    PV-ACREC-04M
    Catalog Number
    PV-ACREC-04M
    Company Name
    ONKOS SURGICAL, INC.
    Labeler DUNS
    080254074
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-22
    Public Version
    1
    Public Version Date
    2023-03-02
    Public Version Status
    New
    Public Device Record Key
    ae4990ad-75a9-416d-ad97-3058c05f2e79

    Device Description

    Acetabular Reconstruction Implant

    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
    Yes
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    GMDN Terms

    Code Name
    60515 Combination-material acetabulum prosthesis

    Identifiers

    Type ID
    Primary B278PVACREC04M0

    Premarket Submissions

    Submission Number Supplement Number
    K212815 000