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510(k) Data Aggregation

    K Number
    K183094
    Device Name
    CyclaPlex Correction System
    Date Cleared
    2019-04-26

    (170 days)

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

    Cycla Orthopedics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CyclaPlex Correction System is intended for the following surgical indications: to assist in the correction of Hallux Valgus deformity by providing reduction of the 1st intermetatarsal angle.
    Device Description
    The CyclaPlex Correction Systemis comprised of the Implant, Accessories and Instrument Set. The Implant device pulls the 1ª metatars al inward to wards 2ª metatars al and reduces the internetatarsal angle to medically accepted values. The implant is comprised of two metallic bone screws with internal polymeric housing connected by UHMW polyethylene multiple sutures cord. The cord is looped at Anchor 2 and secured to Anchor 1 by multiple surgical knots. Tw implants (paired) are implanted to reduce local loads on the bone and reduce loads on the device as well.
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