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    K Number
    K111971
    Device Name
    SYNDE-LOCK SYNDESMOSIS REPAIR KIT
    Manufacturer
    TARSUS MEDICAL INC.
    Date Cleared
    2012-01-23

    (196 days)

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

    TARSUS MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.
    Device Description
    The Synde-Lock™ Syndesmosis Repair Kit contains an implant designed as two bone anchors, one a stainless steel screw and the other a PEEK T-nut, connected by a distribution bridge comprised of UHMWPE suture and a threaded PEEK rod. The stainless steel screw is pre-threaded with the UHMWPE suture section of the distribution bridge. The PEEK T-nut engages the threads of the PEEK section of the distribution bridge allowing the effective length of the bridge to be shortened. A clipper is also contained in the kit to cut away excess distribution bridge material, once the implant is in place. The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.
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    K Number
    K110800
    Device Name
    META-LOCK SUTURE ANCHOR SYSTEM
    Manufacturer
    TARSUS MEDICAL INC.
    Date Cleared
    2011-09-27

    (189 days)

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

    TARSUS MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tarsus Medical Meta-Lock Suture Anchor System is intended for fixation of suture to bone for the indications listed below: SHOULDER: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, Deltoid repair ANKLE: Lateral instability, medial instability, achilles tendon repair/reconstruction, Midfoot reconstructions FOOT: Hallux valgus reconstruction WRIST: Scapholunate ligament HAND: Ulnar or lateral collateral ligament reconstruction ELBOW: Biceps tendon reattachment KNEE: Extra capsular repairs; reattachment of : medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tendonesis; patellar ligament and tendon avulsions.
    Device Description
    The Meta-Lock™ Suture Anchor System is a suture anchor used for the reattachment of soft tissue to bone.
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