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

    MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE

    K Number: K990120 · Decision Feb 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    10
    Review Days
    19

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    Basic Information

    Device Name
    MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
    K Number
    K990120
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Ace Medical Co.
    Date Received
    January 13, 1999
    Decision Date
    February 1, 1999
    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 Depuy Ace Medical Co.

    K Number Device Name
    K990392 DEPUY ACE SPIDER 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
    K974245 DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
    K970503 DEPUY ACE TROCHANTERIC SIDE PLATE
    K970202 DEPUY ACE AIM TITANIUM TIBIAL NAIL