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510(k) Data Aggregation

    K Number
    K092082
    Device Name
    SYNERGY CANNULATED SCREW SYSTEM
    Manufacturer
    SYNERGY SURGICAL TECHNOLOGIES, LLC
    Date Cleared
    2009-10-02

    (85 days)

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

    SYNERGY SURGICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synergy Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsal and phalangeal osteotomies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis; and pelvis and acetabulum fractures. This system is not indicated for use in the spine.
    Device Description
    Synergy Cannulated Screw System
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