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510(k) Data Aggregation

    K Number
    K191771
    Device Name
    SECURE Screw
    Manufacturer
    A.M. Surgical, Inc.
    Date Cleared
    2019-10-16

    (106 days)

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

    A.M. Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SECURE Screw is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
    Device Description
    The A.M. Surgical SECURE Screw is a stainless steel, cannulated, partially threaded, headless screw intended to be used for fracture fixation of small, long bones of the hands and feet. Screw threads provide compression to promote reunion of fracture fragments. The device is offered in five different lengths; 40mm, 45mm, 50mm, 55mm, and 60mm. All dimensions, excluding length, are the same among the different sizes. These varying lengths allow for personalized medical treatment of fractures geared toward each individual patient and different types of fractures. The device is manufactured out of a single piece of 316L VM (UNS-S31673) stainless steel, is provided sterile (via gamma radiation), and is not reusable or re-sterilizable. This device is intended for permanent implantation, but can also be removed. To install and remove the device from a patient, the F543 compliant T8 hexalobe drive connection on the screw head is used in conjunction with a commercially available guide wire, drill bit, and driver.
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    K Number
    K191345
    Device Name
    Pegasus System
    Manufacturer
    A.M. Surgical, Inc.
    Date Cleared
    2019-07-17

    (58 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.M. Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pegasus System is indicated for diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
    Device Description
    The Pegasus System is a portable, disposable, rigid, video camera enabled handheld probe paired with a wireless video receiver. It is powered by internal batteries encased in a plastic handpiece/handle. The distal tip of the stainless steel probe contains a camera and LED light source for visualization. The device is provided sterile and is intended for single patient use.
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    K Number
    K080133
    Device Name
    MOUNTABLE ENDOSCOPIC BLADE
    Manufacturer
    A.M. SURGICAL, INC.
    Date Cleared
    2008-03-13

    (55 days)

    Product Code
    EMF
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.M. SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release. - Carpal tunnel release for carpal tunnel syndrome . - Plantar fasciotomy for plantar fasciitis . - Lateral release of the knee for extensor mechanism malalignment . - Forearm fasciotomy for compartment syndrome - . Morton's neuroma for interdigital neuroma - Gastrocnemius release for heel cord contracture (equinus) .
    Device Description
    The Mountable Endoscopic Blade is a device that mounts to a 4mm 30° endoscope.
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    K Number
    K042458
    Device Name
    A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
    Manufacturer
    A.M. SURGICAL, INC.
    Date Cleared
    2004-10-07

    (27 days)

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

    A.M. SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.
    Device Description
    A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is an external wrist fixator made of titanium , consisting of two (distal and proximal) connecting slide sections with predetermined angled holes. Standard Kirschner wires (K-wire) are inserted through the predetermined angle holes for fracture fixation, three on the distal section and two on the proximal section. The sections can be adjusted distal to proximal and locked into place by way of a center hex screw. The device will be offered sterile and is single use.
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    K Number
    K982142
    Device Name
    MOUNTABLE ENDOSCOPIC KNIFE
    Manufacturer
    A.M. SURGICAL, INC.
    Date Cleared
    1998-12-30

    (196 days)

    Product Code
    EMF
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.M. SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    a) Carpal tunnel release / carpal tunnel syndrome b) plantar fasciotomy/ Plantar fascitis c) lateral release of the knee / extensor mechanism malignment d) forearm fasciotomy / compartment syndrome e) Mortons Neuroma/ Interdigital Neuroma
    Device Description
    Mountable Endoscopic Knife
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