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

    CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM

    K Number: K023096 · Decision Apr 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    70
    Applicant Total
    6
    Review Days
    204

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    Basic Information

    Device Name
    CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
    K Number
    K023096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3690
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Std Mfg., Inc.
    Date Received
    September 18, 2002
    Decision Date
    April 10, 2003
    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 Std Mfg., Inc.

    K Number Device Name
    K021549 CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
    K012362 MODIFICATION TO VASCULAR CLOSURE DEVICE
    K003169 VASCULAR CLOSURE DEVICE
    K000608 SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
    K930427 STD IRRIGATION PUMP