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

    ACE HUMERAL NAIL

    K Number: K934643 · Decision Mar 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    14
    Review Days
    174

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    Basic Information

    Device Name
    ACE HUMERAL NAIL
    K Number
    K934643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ace Orthopedic Manufacturing Co.
    Date Received
    September 29, 1993
    Decision Date
    March 22, 1994
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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    Other Clearances by Ace Orthopedic Manufacturing Co.

    K Number Device Name
    K934962 AIM SUPRACONDYLAR NAIL
    K936045 ACE UNILATERAL FIXATOR II
    K926047 ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW
    K920738 ACE 100 DEGREES TUBULAR PLATE
    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
    K781840 EXTERNAL ARTICULATION
    Search all 14 clearances from Ace Orthopedic Manufacturing Co. →