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510(k) Data Aggregation

    K Number
    K172620
    Device Name
    SyndesMetrics Syndesmosis Repair System
    Date Cleared
    2017-11-08

    (69 days)

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

    Mortise Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SyndesMetrics Syndesmosis Repair System is intended for repair in the ankle including indications for: Ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.
    Device Description
    The SyndesMetrics Syndesmosis Repair System consists of a Fibular Anchor and a Tibial Anchor which are connected by a length of suture. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 3.5mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.
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    K Number
    K171964
    Device Name
    LigaMetrics Suture Anchors
    Date Cleared
    2017-09-19

    (81 days)

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

    Mortise Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LigaMetrics Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction. Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair. 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 collateral ligament reconstruction, Radial collateral ligament reconstruction. Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction. Hip: Distal row abductor tendon repair
    Device Description
    The LigaMetrics Suture Anchors are offered in Threaded and Push-In versions and are designed to secure soft tissue to bone. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 2.0mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.
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