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

    SPACER-S

    K Number: K112983 · Decision Dec 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    70
    Applicant Total
    14
    Review Days
    67

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    Basic Information

    Device Name
    SPACER-S
    K Number
    K112983
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3690
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tecres S.P.A.
    Date Received
    October 6, 2011
    Decision Date
    December 12, 2011
    Product Code
    HSD
    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
    HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

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    Other Clearances by Tecres S.P.A.

    K Number Device Name
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    K220131 KYPHON VuE Bone Cement
    K181732 InterSpace Knee Extra-Large Size, InterSpace Knee ATS
    K122175 MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
    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
    K062273 SPACER-G TEMPORARY HIP PROSTHESIS
    K063438 VSPSPN
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