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

    DePuy Synthes Trauma Screws

    K Number: K192745 · Decision Nov 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    5
    Review Days
    57

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    Basic Information

    Device Name
    DePuy Synthes Trauma Screws
    K Number
    K192745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
    Date Received
    September 30, 2019
    Decision Date
    November 26, 2019
    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 Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

    K Number Device Name
    K181933 DePuy Synthes Sterilization Container System
    K180310 DePuy Synthes Trauma Orthopedic Plates and Screws
    K172975 DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
    K160553 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S