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

    ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW

    K Number: K926047 · Decision Mar 31, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    14
    Review Days
    120

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    Basic Information

    Device Name
    ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW
    K Number
    K926047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ace Orthopedic Manufacturing Co.
    Date Received
    December 1, 1992
    Decision Date
    March 31, 1993
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Ace Orthopedic Manufacturing Co.

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    K813554 ACE/KYLE CAPTURED HIP SCREW
    K810193 TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG
    K801594 ACE FISCHER EXTERNAL FIXATION DEVICE
    K791466 ACE EXTERNAL BONE CLAMP PART #S11
    K781839 BONE CLAMP, ACE EXTERNAL
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