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510(k) Data Aggregation

    K Number
    K203855
    Device Name
    CoNextions TR Tendon Repair System
    Manufacturer
    CoNextions Medical
    Date Cleared
    2022-04-22

    (477 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    CoNextions Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CoNextions TR Tendon Repair System is indicated for the repair of severed Tendons in adults (22 years of age or older). The product is intended for the following indications: - Digital Flexor Tendons - Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8)
    Device Description
    The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.
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    K Number
    K200028
    Device Name
    Coronet Soft Tissue Fixation System
    Manufacturer
    CoNextions Medical
    Date Cleared
    2020-03-04

    (58 days)

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

    CoNextions Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coronet Soft Tissue Fixation System is intended for fixation of tissue to bone and tissue to tissue. This product is intended for the following indications: - Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair - Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair - Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament Reconstruction - Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial Ligament Reconstruction
    Device Description
    The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.
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