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

    MedCAD® AccuStride™ System

    K Number: K252064 · Decision Mar 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    26
    Applicant Total
    9
    Review Days
    269

    Basic Information

    Device Name
    MedCAD® AccuStride™ System
    K Number
    K252064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medcad
    Date Received
    July 1, 2025
    Decision Date
    March 27, 2026
    Product Code
    PBF
    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
    PBF Orthopaedic Surgical Planning And Instrument Guides

    Similar 510(k) Clearances

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

    VSP Orthopedics System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MyPAO SA guides

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MedCAD® AccuStride™ System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Fine TTO™

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Newclip Patient-matched instrumentation non sterile PSI

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORIOGRAPH Pre-Op Planning and Modeling Services

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

    Other Clearances by Medcad

    K Number Device Name
    K251709 MedCAD® AccuStride™ System
    K241811 MedCAD® AccuStride™ System
    K230398 MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
    K223421 MedCAD AccuPlan Orthopedics System
    K223024 MedCAD AccuPlan System
    K220357 MedCAD AccuShape Titanium Patient-Specific Cranial Implant
    K193280 MedCAD® AccuPlate® Patient-Specific Plate
    K192282 MedCAD® AccuPlan® System