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510(k) Data Aggregation

    K Number
    K231400
    Device Name
    Bladeless Trocar – Artemis Lap Cannula
    Manufacturer
    T.A.G. Medical Products Corporation, Ltd
    Date Cleared
    2023-08-04

    (81 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    T.A.G. Medical Products Corporation, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.
    Device Description
    Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.
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    K Number
    K230058
    Device Name
    Bladeless Trocar – Artemis Lap Cannula
    Manufacturer
    T.A.G. Medical Products Corporation, Ltd
    Date Cleared
    2023-04-28

    (109 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    T.A.G. Medical Products Corporation, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.
    Device Description
    Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.
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    K Number
    K221731
    Device Name
    FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
    Manufacturer
    T.A.G. Medical Products Corporation, Ltd
    Date Cleared
    2022-09-07

    (84 days)

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

    T.A.G. Medical Products Corporation, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FiberStitch™ Implant is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Implant Device is indicated for use in rotator cuff and meniscal repair procedures.
    Device Description
    Not Found
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    K Number
    K210498
    Device Name
    Betta Link Knotless Implant System
    Manufacturer
    T.A.G. Medical Products Corporation, Ltd
    Date Cleared
    2021-03-24

    (30 days)

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

    T.A.G. Medical Products Corporation, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Betta Link™ Knotless Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
    Device Description
    The Betta Link™ Knotless Anchor System consists of an inserter and PEEK (Polyether-ether-ketone) non-absorbable anchor. The device is a manual surgical device and is comprised of a handle and PEEK anchor on a proximal (to user) edge of the inserter shaft. The inserter shaft ends with a dedicated "fork" tip which holds the anchor. The handle is designed for hammering the inserter into the pilot hole to deploy the anchor. When the anchor is inserted into bone and the inserter is removed the fixation is achieved.
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    K Number
    K202178
    Device Name
    VersaLoop Anchor System
    Manufacturer
    T.A.G. Medical Products Corporation, Ltd
    Date Cleared
    2020-11-13

    (101 days)

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

    T.A.G. Medical Products Corporation, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VersaLoop™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
    Device Description
    The VersaLoop™ Anchor System consists of an inserter and Ultra High Molecular Weight Polyethylene (UHMWPE) non-absorbable loop suture anchor and threaded sutures. The inserter shaft ends with a "fork" tip which holds the suture anchor. There are 3 narrow slots on the handle which holds the suture, which can be press-locked and released. The handle is designed for hammering the inserter into the pilot hole to deploy the anchor. When the suture anchor is inserted into bone and the inserter is removed, the main sutures are pulled, and the all-suture anchor (loop) creates a "bunching" effect using targeted compression zones within the implant sheath for optimal fixation.
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    K Number
    K190125
    Device Name
    FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
    Manufacturer
    T.A.G. Medical Products Corporation, Ltd
    Date Cleared
    2019-05-19

    (111 days)

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

    T.A.G. Medical Products Corporation, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FiberStitch™ Meniscal Repair Device is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™M Meniscal Repair Device is indicated for use in meniscal repair procedures.
    Device Description
    The FiberStitch™ devices are an all-inside meniscal repair device. The devices include two non-absorbable polyester implants, pre-tied with #2-0 non-absorbable sutures and preloaded into a needle delivery system. The adjustable depth penetration limiter is preset to approximately 18mm from the tip of the needle. It can be adjusted down in 2 (mm) increments to approximately 10mm.
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    K Number
    K143326
    Device Name
    T.A.G. Dental Implant System
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD
    Date Cleared
    2015-05-14

    (175 days)

    Product Code
    DZE, CLA, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T.A.G. Dental Implant System is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The T.A.G.'s Dental Implant System is composed of three sub-families: (1) Massif - A self-tapping cylindrical screw type implant Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 6 mm not available for diameters below 4.2 mm. (2) Axis - A self-tapping conical implant. Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 8 mm not available for diameters below 3.75 mm, length 16 mm not available for diameters above 4.2 (3) Crestone - A one piece implant Available in Lengths of 10 - 16 mm and Diameters 3.0 - 3.5 mm. The implants are provided sterilize for single patient use. Each implant is provided with cover screw inside the sterile package. All implants are made of titanium alloy grade 23 (Ti-6AI-4V-ELI). Provided are accessories which are used in dental implantation procedures. They are: Superstructures which are Healing Caps & Abutments made from Titanium Alloy TI 6AL 4V ELI, Stainless Steel, and/or PEEK. The superstructures are single patient use to be supplied non-sterile.
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    K Number
    K142653
    Device Name
    G-Lok and G-Lok XL Extender
    Manufacturer
    T.A.G. Medical Products Corporation, Ltd
    Date Cleared
    2014-10-16

    (28 days)

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

    T.A.G. Medical Products Corporation, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The G-Lok® and G-Lok® XL Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.
    Device Description
    The G-Lok® suspension fixation device is a single-use, titanium implant used for fixation of soft tissue to bone. The G-Lok® has two configurations: One has a Continuous Loop, made of ultra high molecular weight polyethylene, offered in several sizes to accommodate various bone tunnel lengths. The second configuration does not have a loop, and enables custom loop lengths to be tied using an appropriate material (not included). Both of these configurations have a Lead Suture and an optional Flipping Suture. The G-Lok® XL Extender is a single-use, titanium implant used for providing additional button width and length to the G-Lok®.
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    K Number
    K113297
    Device Name
    KNOTILUS ANCHOR SYSTEM
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
    Date Cleared
    2012-03-02

    (115 days)

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

    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Knotilus™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
    Device Description
    The Knotilus Anchor System consists of: • Knotilus Anchor - an implantable anchor preloaded on a disposable inserter to aid with anchor insertion into the bone. The Knotilus Anchor will be offered in outer diameters ranging from 3.5 mm to 6.0 mm and length ranging from 10 mm to 20 mm. • Knotilus Implant Loop - A non-absorbable UHMWPE (Dyneema) loop designed for fixation of soft tissue without the need of knot tying. The Knotilus Implant Loop will be offered with a total length of 470 mm and distal loop sizes of 22 mm, 25 mm and 28 mm. The Knotilus Anchor and Knotilus Implant Loop will be provided separately, sterile for single use only.
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    K Number
    K112296
    Device Name
    LATERAL BUTTON
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
    Date Cleared
    2011-12-01

    (114 days)

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

    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lateral Button™ is intended to protect the suture/bone during transosseous fixation procedures.
    Device Description
    The Lateral Button™ consists of an implanted Button preloaded on a disposable inserter necessary for its insertion into the bone tunnel, the inserter is removed upon completion of the procedure. The implant is made of implantable grade PEEK (polyether - etherketone). The inserter is made of Polycarbonate. The Lateral Button and its inserter will be supplied sterile for single use. The implant has an O.D. of 3.1 mm, overall length of 10 mm and an I.D. of 1.8 mm. In use, the suture is threaded through the implant, which helps to distribute the pressure created by the suture and assists in the prevention of suture migration and damage to suture and/or bone. The implant will be supplied either as a stand alone device or as part of a kit i.e. with other devices already cleared for transosseous fixation procedures.
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