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510(k) Data Aggregation

    K Number
    K141499
    Device Name
    X-REPAIRSL
    Manufacturer
    SYNTHASOME, INC.
    Date Cleared
    2014-07-02

    (26 days)

    Product Code
    FTL, OWW
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTHASOME, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    X-RepairSL is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. X-RepairSL is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. X-RepairSL is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.
    Device Description
    The X-RepairSL is a bioabsorbable, rectangular, single-layered, flexible, woven surgical mesh manufactured from poly-i-lactic acid (PLLA) fiber. It has locked top and bottom edges and welded ends. It is provided sterile, intended for single use, and labeled non-pyrogenic.
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    K Number
    K083307
    Device Name
    SYNTHASOME X-REPAIR
    Manufacturer
    SYNTHASOME, INC.
    Date Cleared
    2009-03-27

    (137 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTHASOME, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    X-Repair is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. X-Repair is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. X-Repair is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.
    Device Description
    The X-Repair is a bioabsorbable, rectangular, double-layered, flexible, woven surgical mesh manufactured from poly-l-lactic acid (PLLA) fiber. It has locked top and bottom edges and welded ends. It is provided sterile, intended for single use, and labeled non-pyrogenic.
    Ask a Question

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