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

    DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI

    K Number: K974245 · Decision May 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    56
    Applicant Total
    10
    Review Days
    191

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    Basic Information

    Device Name
    DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
    K Number
    K974245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Ace Medical Co.
    Date Received
    November 12, 1997
    Decision Date
    May 22, 1998
    Product Code
    LXT
    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
    LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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    Other Clearances by Depuy Ace Medical Co.

    K Number Device Name
    K990392 DEPUY ACE SPIDER PLATE
    K990120 MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
    K984458 DEPUY ACE SPIDER PLATE
    K983853 DEPUY ACE TIMAX META PLATE
    K983265 DEPUY ACE COMPOSITE LOCKING NUT
    K982347 DEPUY ACE TIMAX PILON PLATE
    K981775 DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE
    K970503 DEPUY ACE TROCHANTERIC SIDE PLATE
    K970202 DEPUY ACE AIM TITANIUM TIBIAL NAIL