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

    RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS

    K Number: K112897 · Decision Jun 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    19
    Applicant Total
    9
    Review Days
    254

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    Basic Information

    Device Name
    RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
    K Number
    K112897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovis Surgical Technologies, LLC
    Date Received
    October 3, 2011
    Decision Date
    June 13, 2012
    Product Code
    OQG
    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
    OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

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    Other Clearances by Renovis Surgical Technologies, LLC

    K Number Device Name
    K132312 RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
    K131354 RENOVIS BIPOLAR HIP SYSTEM
    K131122 S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
    K120038 A200 KNEE SYSTEM
    K111940 S 100 PEDICLE SCREW SYSTEM
    K113084 RENOVIS CANNULATED SCREW SYSTEM
    K110965 RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
    K101682 S 100 PEDICLE SCREW SYSTEM