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510(k) Data Aggregation

    K Number
    K141559
    Device Name
    V-GUIDE FOR VENTRICULOSTOMIES
    Manufacturer
    ARC SURGICAL LLC.
    Date Cleared
    2015-02-27

    (260 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARC SURGICAL LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters.
    Device Description
    The V-Guide is a sterile, single use, Neurological Stereotactic Instrument that provides the surgeon with a localized reference guide for performing Ventriculostomies. The device is compatible with 3.3mm ventricular catheters. The device consists of a Base Assembly, three Impression Pins (16 Gauge Stainless Steel needles with aluminum hubs) that act as legs for the Base, a Pierce Sagittal assembly and a Pierce Barrel. The device allows the user to orient the sagittal plane to 0° and the lateral plane to 0°. This aligns the device to a perpendicular track to the entry point. A standard 3.3mm catheter is then passed through the guide into the brain at the predetermined distance as in a standard Ventriculostomy. If the flow of cerebrospinal fluid is noted and the surgeon is satisfied the position of the catheter, the V-guide can be removed from the catheter by removing the barrel. If the surgeon is not satisfied with the position of the catheter, the catheter is removed and this technique can be repeated with different angles to allow for an objective change in direction of the catheters angle to the cranium.
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    K Number
    K071616
    Device Name
    ARC SURGICAL BIOTRAK PIN SYSTEM
    Manufacturer
    ARC SURGICAL LLC.
    Date Cleared
    2007-12-19

    (189 days)

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

    ARC SURGICAL LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIOTRAK™ Pin is intended for use in fixation and/or alignment of fragments and fractures of non-load bearing bones, osteotomies, arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities.
    Device Description
    The ARC Surgical BIOTRAK TM Pin System is composed of pins injection molded from poly-L-lactic acid (PLLA) with diameter 1.5mm to 2.0mm and length 20mm to 40mm. External features on the pin provide increased resistance to loosening of bone fragments. The screws are provided sterile.
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    K Number
    K063244
    Device Name
    ARC SURGICAL BONE REDUCTION SCREW
    Manufacturer
    ARC SURGICAL LLC.
    Date Cleared
    2006-12-27

    (62 days)

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

    ARC SURGICAL LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bone Reduction Screw is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
    Device Description
    The ARC Surgical Bone Reduction Screw is a headless, cannulated twopiece screw assembly. The two-piece design incorporates the use of a distal and proximal screw component. The implant is used to anatomically reduce two bone portions. The distal screw component engages the distal bone portion and the proximal screw component engages the proximal bone component.
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    K Number
    K061763
    Device Name
    ARC SURGICAL BIOTRAK SCREW
    Manufacturer
    ARC SURGICAL LLC.
    Date Cleared
    2006-09-19

    (89 days)

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

    ARC SURGICAL LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biotrak™ resorbable compression screw is intended to provide fixation and/or reduction of small bone fractures, osteotomies, and arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities. Specifically, these indications include osteochondral defects (OCDs), patella rim fractures, metatarsal fusions and fractures, metatarsal osteotomies, hallux valgus corrections, humeral condyle fractures, metacarpal fusions and fractures, carpal fusions and fractures, radial head fractures, and distal radius fractures.
    Device Description
    The ARC Surgical Biotrak™ Screw System is composed of screws injection molded from poly-L-lactic acid (PLLA) with diameter (4.3mm to 4.8mm) and length (16mm to 24mm). Headless screw compression is obtained from the variable pitch of the threads. The screws are provided sterile.
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    K Number
    K043176
    Device Name
    ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
    Manufacturer
    ARC SURGICAL LLC.
    Date Cleared
    2005-06-17

    (213 days)

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

    ARC SURGICAL LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARC Surgical Resorbable Compression Screw System is a bioabsorbable PLLA screw intended to provide fixation and/or reduction of bone fragments and bones. Specifically, as listed below, the screw is intended to fix osteochondral fragments, osteotomies and fractures in the foot, and limited fractures in the wrist, elbow, and ankle. - . Osteochondral fragments - Femoral condyle o - Talus 0 - Navicular ্ - Hallux Valgus correction ● - Tarsal fractures . - Distal Radius fractures ● - Radial Head fractures .
    Device Description
    The ARC Surgical Resorbable Compression Screw System is composed of screws injection molded from poly-L-lactic acid (PLLA) with diameter (4.3mm to 4.8mm) and length (16mm to 24mm). Headless screw compression is obtained from the varying pitch of the threadless screw has a tapered square cannulation and the driver has a square-shaped geometry to drive the screw. The screws are provided sterile.
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