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

    AOS CANNULATED BONE SCREW SYSTEM

    K Number: K014185 · Decision Feb 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    653
    Registration Numbers
    653
    Same Product Code
    1040
    Applicant Total
    19
    Review Days
    55

    Basic Information

    Device Name
    AOS CANNULATED BONE SCREW SYSTEM
    K Number
    K014185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
    Date Received
    December 20, 2001
    Decision Date
    February 13, 2002
    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 ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

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    K141228 AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
    K133081 TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N
    K132005 RETROGRADE FEMORAL NAIL
    K123569 ANTEGRADE FEMORAL NAIL
    K130625 12MM AND 13MM TIBIAL NAILS
    K120148 AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW
    K122623 SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT
    K103513 LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA
    Search all 19 clearances from ADVANCED ORTHOPAEDIC SOLUTIONS, INC. →