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

    ORTHOHELIX STAPLE SYSTEM

    K Number: K142148 · Decision Aug 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    25
    Review Days
    16

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    Basic Information

    Device Name
    ORTHOHELIX STAPLE SYSTEM
    K Number
    K142148
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthohelix Surgical Designs, Inc.
    Date Received
    August 5, 2014
    Decision Date
    August 21, 2014
    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

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    Other Clearances by Orthohelix Surgical Designs, Inc.

    K Number Device Name
    K141004 INTRAOSSEOUS FIXATION SYSTEM
    K141301 MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
    K132733 ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
    K132591 MAXLOCK EXTREME SYSTEM
    K130832 ORTHOHELIX STAPLE SYSTEM
    K131324 MAXTORQUE SCREW SYSTEM
    K123203 MAXLOCK EXTREME SYSTEM MODEL MXL
    K122005 MAXLOCK EXTREME SYSTEM
    K121437 MINI MAXLOCK EXTREME PLATING SYSTEM
    K120165 INTRAOSSEOUS FIXATION SYSTEM
    Search all 25 clearances from Orthohelix Surgical Designs, Inc. →