BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    StealthFix Intraosseous Fixation System

    K Number: K232324 · Decision Aug 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    5
    Review Days
    27

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    StealthFix Intraosseous Fixation System
    K Number
    K232324
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medartis, Inc.
    Date Received
    August 3, 2023
    Decision Date
    August 30, 2023
    Product Code
    JDR
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JDR Staple, Fixation, Bone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JDR), ordered by most recent decision date.

    Linkt Compression Staple System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Medline UNITE® REFLEX® Hybrid Nitinol Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex DynaNite Nitinol Staples

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TMC Compression Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TMC Compression Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COGNiTiON™ Staple System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Medartis, Inc.

    K Number Device Name
    K052061 MODUS IMF SCREWS 2.0
    K051567 APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
    K051946 MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM
    K050934 MODUS TITANIUM OSTEOSYNTHESIS SYSTEM