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510(k) Data Aggregation

    K Number
    K142135
    Device Name
    REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
    Manufacturer
    ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
    Date Cleared
    2014-08-28

    (24 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EDGE Orthopaedics' REDUCE® Fracture Plating System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws. Plates and screws are intended for single use only. Screws are not intended for use in the spine.
    Device Description
    The EDGE Orthopaedics' REDUCE® Fracture Plating System Line Extension has been designed to support multiple indications within the forefoot and mid-foot. The line extension includes titanium alloy, sterile packaged H and Box Plates along with sterile titanium alloy bone screws. The REDUCE Fracture Plating System is offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones. The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray. The only modifications that were made are the two additional fracture plates: H-plate and Box plate. The manufacturing, packaging and sterilization process are the same as the predicate device.
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    K Number
    K140876
    Device Name
    VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
    Manufacturer
    ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
    Date Cleared
    2014-07-22

    (106 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EDGE Orthopaedics' VIEW™ and REDUCE™ Plating Systems are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws. Plates and screws are intended for single use only. Screws are not intended for use in the spine.
    Device Description
    The EDGE Orthopaedics' VIEW™ Plating System has been designed to support multiple indications within the mid-foot. The system includes titanium alloy, sterile packaged Lapidus, First Metatarsophalangeal (MTP), Calcaneal-Cuboid (CC), Evans and Talonavicular (TN) Plates along with sterile titanium alloy bone screws. The design creates a "window" offering a continuous view into the healing process. The EDGE Orthopaedics' REDUCE® Fracture Plating System has been designed to support multiple indications within the forefoot and mid-foot. The system includes titanium alloy, sterile packaged T. L. Y. and Straight Plates along with sterile titanium alloy bone screws. VIEW and REDUCE Plating Systems are offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones. The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray.
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