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510(k) Data Aggregation

    K Number
    K173269
    Device Name
    KATOR Suture Anchor
    Manufacturer
    KATOR LLC
    Date Cleared
    2018-05-30

    (230 days)

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

    KATOR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Shoulder: Rotator Cuff Repairs, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Hip: Capsular Repair, Acetabular Labral Repair.
    Device Description
    The KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair suture tape within the implant.
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    K Number
    K162386
    Device Name
    KATOR Suture Anchor
    Manufacturer
    KATOR LLC
    Date Cleared
    2016-10-25

    (61 days)

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

    KATOR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.
    Device Description
    The modified KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair sutures or suture tape within the implant.
    Ask a Question
    K Number
    K152236
    Device Name
    KATOR Suture Anchor
    Manufacturer
    KATOR LLC
    Date Cleared
    2015-11-04

    (86 days)

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

    KATOR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.
    Device Description
    The KATOR Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone.
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