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510(k) Data Aggregation

    K Number
    K193108
    Device Name
    Bonecam Suture Anchor
    Manufacturer
    Valeris Medical Inc.
    Date Cleared
    2020-03-26

    (139 days)

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

    Valeris Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shoulder - Rotator Cuff Repair - · Bankart Repair - · SLAP Lesion Repair - · Biceps Tenodesis - · Acormio-Clavicular Separation Repair - · Deltoid Repair - Capsular Shift or Capsulolabral Reconstruction Hand and Wrist - Scapholunate Ligament Reconstruction - Carpal Ligament Reconstruction - · Repair/Reconstruction of collateral ligaments - · Repair of flexor and extensor tendons at the PIP, DIP, and MCP joints for all digits - · Digital tendon transfers Elbow - Biceps Tendon Reattachment - · Ulnar or Radial Collateral Ligament Reconstruction Hip - · Capsular Repair - Acetabular Labral Repair Foot and Ankle - Lateral stabilization - Medial stabilization - · Achilles tendon repair - · Metatarsal ligament repair - Hallux valgus reconstruction - Digital tendon transfers - Mid-foot reconstruction Knee - Medial collateral ligament repair - Lateral collateral ligament repair - Posterior oblique ligament repair - Illiotibial band tenodesis reconstruction - Patellar ligament/tendon repair
    Device Description
    The BoneCam Suture Anchor Delivery Systems are for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The BoneCam Suture Anchor Delivery System consists of a single anchor with integrated multiple suture attachment. The anchors are provided loaded on individual inserters with integrated sutures with or without needles, sterile (EtO), for single use only. The BoneCam Suture Anchor Delivery Systems have a shelf life of 2 years. Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).
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