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

    SPACER-G TEMPORARY HIP PROSTHESIS

    K Number: K062273 · Decision May 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    14
    Review Days
    654

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    Basic Information

    Device Name
    SPACER-G TEMPORARY HIP PROSTHESIS
    K Number
    K062273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tecres S.P.A.
    Date Received
    August 7, 2006
    Decision Date
    May 22, 2008
    Product Code
    KWL
    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
    KWL Prosthesis, Hip, Hemi-, Femoral, Metal

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    Other Clearances by Tecres S.P.A.

    K Number Device Name
    K252326 InterSpace GV Hip Spacer
    K211163 Bone Cement Genta, Bone Cement HV, Bone Cement LV
    K220131 KYPHON VuE Bone Cement
    K181732 InterSpace Knee Extra-Large Size, InterSpace Knee ATS
    K122175 MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
    K112983 SPACER-S
    K101356 Spacer-G and Spacer-K
    K092773 CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST
    K062274 SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
    K063438 VSPSPN
    Search all 14 clearances from Tecres S.P.A. →