BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    K2™

    DI: 10381780257240 · Model: HEMISET · Ascension Orthopedics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K2™
    Primary DI
    10381780257240
    Version / Model
    HEMISET
    Company Name
    Ascension Orthopedics, Inc.
    Labeler DUNS
    942377524
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-25
    Public Version
    6
    Public Version Date
    2023-05-02
    Public Version Status
    Update
    Public Device Record Key
    1553a8dc-bb4f-46be-918e-0f057f5bfa84
    Distribution End Date
    2023-03-31

    Device Description

    K2™ Hemi Instrument Set (20-6000)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    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
    KWD PROSTHESIS, TOE, HEMI-, PHALANGEAL

    GMDN Terms

    Code Name
    33696 Partial metatarsophalangeal joint prosthesis

    Identifiers

    Type ID
    Secondary M248HEMISET1
    Primary 10381780257240

    Customer Contacts

    Phone
    +1(800)654-2873
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K023770 000