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

    S 100 PEDICLE SCREW SYSTEM

    K Number: K111940 · Decision May 15, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    9
    Review Days
    312

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    Basic Information

    Device Name
    S 100 PEDICLE SCREW SYSTEM
    K Number
    K111940
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovis Surgical Technologies, LLC
    Date Received
    July 8, 2011
    Decision Date
    May 15, 2012
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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    Other Clearances by Renovis Surgical Technologies, LLC

    K Number Device Name
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    K131122 S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
    K120038 A200 KNEE SYSTEM
    K112897 RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
    K113084 RENOVIS CANNULATED SCREW SYSTEM
    K110965 RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
    K101682 S 100 PEDICLE SCREW SYSTEM