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

    SKAFFOLD CIS

    K Number: K111538 · Decision Oct 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    10
    Review Days
    145

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    Basic Information

    Device Name
    SKAFFOLD CIS
    K Number
    K111538
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Skeletal Kinetics, LLC
    Date Received
    June 2, 2011
    Decision Date
    October 25, 2011
    Product Code
    MTJ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MTJ Wax, Bone

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    Other Clearances by Skeletal Kinetics, LLC

    K Number Device Name
    K162864 OsteoVation Impact
    K132211 SKAFFOLD NMX BONE VOID FILLER
    K120354 BETA-TCP GRANULES
    K112383 CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
    K100986 CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
    K051784 OSTEOVATION CMF BONE VOID FILLER
    K051123 CALLOS IMPACT AND INJECT BONE VOID FILLER
    K042072 CALLOS CMF BONE VOID FILLER
    K030554 CALLOS