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510(k) Data Aggregation

    K Number
    K160069
    Device Name
    Sonoma Fibula Repair System
    Manufacturer
    Sonoma Orthopedics Products, Inc
    Date Cleared
    2016-03-10

    (57 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sonoma Orthopedics Products, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.
    Device Description
    The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures and osteotomies. The Sonoma Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.
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    K Number
    K150376
    Device Name
    Sonoma Cancellous Bone Screw and Washer
    Manufacturer
    Sonoma Orthopedics Products, Inc
    Date Cleared
    2015-06-12

    (119 days)

    Product Code
    HWC, HTN
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sonoma Orthopedics Products, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonoma Cancellous Screws are intended for use in the fixation of bone fractures appropriate for the size of the screw. The washer is used to increase bone contact area and prevent the screw head from subsiding into the bone. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
    Device Description
    Sonoma Cancellous Bone Screws and Washers are a family of stainless steel screws and washers used for various skeletal repairs where cancellous screw thread profiles are clinically desired. The screws are offered in range of diameters from 4mm to 7.3mm, in both cannulated and solid configurations. The screw dimensions including thread profile, thread length, core diameter, cannulation diameter (where applicable), head diameter, overall length, and driving socket size are equivalent to the predicate device. Where applicable, these features are dimensioned as described by ASTM F543-13 (i.e. 4.0mm and 6.5mm solid screws). The washers are sized according to screw diameter and can be used to prevent head subsidence in soft bone. The screws and washers are manufactured from 316 stainless steel per ASTM F138.
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