BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Horizon Subtalar Gen 2 7mm

    DI: M20922643 · Model: 22643 · BIOPRO, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Horizon Subtalar Gen 2 7mm
    Primary DI
    M20922643
    Version / Model
    22643
    Company Name
    BIOPRO, INC.
    Labeler DUNS
    618749857
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-23
    Public Version
    3
    Public Version Date
    2025-02-06
    Public Version Status
    Update
    Public Device Record Key
    77c869e6-bdcd-4047-8f4f-8d64385464fb

    Device Description

    Subtalar Arthroerisis 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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    HWC Screw, Fixation, Bone

    GMDN Terms

    Code Name
    40352 Subtalar implant, non-bioabsorbable

    Identifiers

    Type ID
    Primary M20922643

    Premarket Submissions

    Submission Number Supplement Number
    K041936 000