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510(k) Data Aggregation

    K Number
    K170518
    Device Name
    In2Bones Fracture and Correction System
    Manufacturer
    In2BonesUSA, LLC
    Date Cleared
    2017-07-14

    (143 days)

    Product Code
    HRS, HTN, HWC, REV
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    In2BonesUSA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal. The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
    Device Description
    The In2Bones Fracture and Correction System is a system of plates, screws and washers used to treat fracture and reconstruction of the bones of the extremities.
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    K Number
    K163293
    Device Name
    Colink™ Plating System
    Manufacturer
    IN2BONESUSA, LLC
    Date Cleared
    2017-05-05

    (164 days)

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

    IN2BONESUSA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
    Device Description
    The In2Bones CoLink™ Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the bones of the extremities.
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    K Number
    K161426
    Device Name
    NeoSpan Compression Staple Impant w/instruments
    Manufacturer
    IN2BONESUSA, LLC
    Date Cleared
    2016-10-24

    (154 days)

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

    IN2BONESUSA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
    Device Description
    The In2Bones NeoSpan™ Compression Staple Implant w/instruments is a super elastic compression staple made of superelastic Nitinol. The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs.
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    K Number
    K153609
    Device Name
    RTS Flexible 1 MPJ Implant w/Grommets
    Manufacturer
    In2BonesUSA, LLC
    Date Cleared
    2016-09-08

    (266 days)

    Product Code
    KWH
    Regulation Number
    888.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    In2BonesUSA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of: - Hallux limitus or hallux rigidus - Painful rheumatoid arthritis - Hallux abducto valgus associated with arthritis - Unstable or painful joint from previous surgery
    Device Description
    The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
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