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510(k) Data Aggregation

    K Number
    K232780
    Device Name
    CC-Clip® Implant System
    Manufacturer
    CC-Instruments Inc
    Date Cleared
    2023-12-18

    (98 days)

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

    CC-Instruments Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CC-Clip® device is intended as an adjunct in coracoclavicular ligament disruption repair. Specifically, the CC-Clip® device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
    Device Description
    CC-Clip® is an implantable device for an arthroscopic coracoclavicular (CC) ligament reconstruction and acromioclavicular (AC) ligament reconstruction technique. The original ligaments fail due to an AC joint separation and cause superior and posterior translation of the clavicle. CC-Clip® device consists of a titanium implant on the clavicle, a titanium counterpart under the coracoid, and non-resorbable suture between the implants. A USP size 5 suture is not provided with CC-Clip®, but the Arthrex #5 FiberWire is recommended with the CC-Clip® device. Instrumentation included with the CC-Clip® system includes two instruments: the CC-Clip® Straight Lasso guide and CC-Clip® Curved Lasso guide. Additional general-use, readily available instrumentation required for the CC-Clip® procedure includes lasso wire, guide pins, and drill bits which are to be supplied by the end user per the surgical technique. Both CC-Clip® guides are re-usable surgical instruments provided non-sterile to the user. The CC-Clip® implants are supplied sterile to the user and are single use.
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