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510(k) Data Aggregation

    K Number
    K090530
    Device Name
    SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01
    Manufacturer
    ROSS CREEK MEDICAL INC.
    Date Cleared
    2009-05-20

    (82 days)

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

    ROSS CREEK MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ross Creek Spin-Loc Suture Anchor System is intended to be used for soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is intended for use in the following procedures: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capsular Shift/Capsulolabral Reconstruction Foot and 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 - Illiotibial Band Tenodesis Elbow - Biceps Tendon Reattachment The Ross Creek Spin-Loc Suture Anchor System is intended for single-use only.
    Device Description
    The Spin-Loc Suture Anchor System consists of a PEEK polymer and stainless steel or cobalt chromium alloy suture anchor loaded on an insertion handle. The Spin-Loc anchor is designed to facilitate fixation of soft tissue to bone. The design allows the surgeon to adjust the tension on the tissue after insertion of the anchor into bone. The Spin-Loc Suture Anchor System will be validated to a SAL of 10-6 using ethylene oxide. The ethylene oxide residuals will be tested according to ISO10993-7.
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