BEUDAMED
    Product Code: PBF FDA class 2 21 CFR 888.3030

    Orthopaedic Surgical Planning And Instrument Guides

    Orthopedic

    The Orthopaedic Surgical Planning and Instrument Guides are surgical instruments designed to assist in pre-operative planning and/or guiding the marking of bone and guiding surgical instruments during orthopedic procedures. They fall under the Orthopedic medical specialty and are classified as a Class 2 device under regulation 888.3030, requiring 510(k) premarket notification. These guides are subject to general controls and special controls to ensure their accuracy and safety in surgical settings. They are not implants and are not life-sustaining.

    View on FDA
    510(k)s
    27
    FEI Numbers
    37
    Registration Numbers
    37
    Unique Applicants
    15
    Years Active
    14

    Research product code PBF in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    PBF
    Device Class
    FDA class 2
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 27 510(k) clearances via K numbers.

    K Number Device Name
    K252064 MedCAD® AccuStride™ System
    K250711 VSP Orthopedics System
    K242603 MyPAO SA guides
    K251709 MedCAD® AccuStride™ System
    K250394 Fine TTO™
    K250767 Newclip Patient-matched instrumentation non sterile PSI
    K250921 CORIOGRAPH Pre-Op Planning and Modeling Services
    K241811 MedCAD® AccuStride™ System
    K243912 Newclip Patient-matched instrumentation non sterile PSI
    K240415 Newclip Patient-matched instrumentation non sterile PSI
    K240113 CORIOGRAPH Knee Pre-Op Plan
    K240066 Fine Osteotomy™
    K221615 Newclip Patient-matched instrumentation non sterile PSI
    K223421 MedCAD AccuPlan Orthopedics System
    K231314 Fine Osteotomy™
    K220706 MyPAO Guides
    K221943 EmbedMed
    K211614 CenterMed Patient Matched Assisted Surgical Planning (ASP) System
    K211076 Patient Specific Marking Guides
    K220717 RedPoint Medical's Better Bunion System
    K212237 3D-Cut
    K211244 VSP® Orthopedics System
    K192979 KLS Martin Individual Patient Solutions (IPS) Planning System
    K190044 VSP Orthopedics System
    K163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
    K132290 SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
    K112389 SURGICASE CONNECT, SURGICASE GUIDE

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.