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510(k) Data Aggregation

    K Number
    K964226
    Device Name
    MEMORY STAPLE (20 SIZES AVAILABLE)
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1997-08-05

    (286 days)

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

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Fixing the osteotomies and arthrodesis of the mid fout bones, the metatarsals, the phalanges, and associated joints of the foot.
    Device Description
    The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.
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    K Number
    K971068
    Device Name
    34MM SCARF THREAD-HEAD(TM) SCREW
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1997-07-09

    (107 days)

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

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the mid-foot, metatarsals and phalanges of the foot.
    Device Description
    The 34mm SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 34mm in length. It is made of thanium alloy and is cannulated with a threaded head. This screw is an extension of the product line for the SCARF Thread-Head Screw.
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    K Number
    K971069
    Device Name
    TWIST-OFF (TM) SCREW
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1997-07-09

    (107 days)

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

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.
    Device Description
    The Twist off Screw is made of titanium alloy and consists of a screw integrated with separates from the screw when the head meets cortical bone. It is 2.0mm in diameter and 11 to 14mm in length and has a selftapping tip.
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    K Number
    K971070
    Device Name
    SCARF THREAD-HEAD (TM) HEAD SCREW
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1997-07-09

    (107 days)

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

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.
    Device Description
    The SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 10 to 34mm in length (in 2mm increments). It is made of titanium alloy and is cannulated with a threaded head.
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    K Number
    K961732
    Device Name
    KAR
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1997-07-08

    (431 days)

    Product Code
    MEH, LZO
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This prosthesis is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is sufficient healthy cortical bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, internal fixation, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
    Device Description
    The KAR Revision Hip is a non-cemented, long femoral stem made from Ti-6Al-4V, completely coated with hydroxyapatite. It has a straight stem with a quadrangular cross-section and blunt corners. The metaphyseal widening presents a bi-dimensional flare and horizontal and vertical grooves for metaphyseal support. The step-like structure of the grooves in the metaphyseal section provides stability. The distal section has symmetrical slopes. The diaphyseal section provides a distal anchor while the distal cross-slotted tip allows for elasticity in the stem and adaptability to the femoral curve. The stem has a 12/14 Morse-like taper.
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    K Number
    K970846
    Device Name
    22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1997-06-05

    (90 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the 22.2/-4 Femoral Head is to complete the assembly of a Ti-6Al-4V semicanus and I he mended tise for the 22.27-4 rendral to the tapen of the Morphonetic Hip, manufactures by Medinov-AMP. The indications for use are artintis, arthrosis or any joint disease at the hip level, of wromans is, failed previous surgery or joint reconstruction.
    Device Description
    The 22.2/44 Femoral Head is designed to fit on a 9/11 taper. It is 22.2mm in diameter and has a neck length of +4. It is available in zirconia or cobalt chrome alloy.
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    K Number
    K953111
    Device Name
    CORAIL
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1996-12-27

    (543 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORAIL® Total Hip Prosthesis is designed to restore hip mobility.
    Device Description
    CORAIL® is a single-use, non-cemented, HA-coated prosthesis. The CORAIL® Total Hip Prosthesis is a complete set and consists of: - femoral stem, made of titanium alloy and completely coated with hydroxyapatite, with a 12/14 morse taper; available with or without collar. It is grooved both vertically and horizontally to provide stability against driving in and rotation. - Alumina or cobalt chrome femoral head - acetabular cup, made of titanium alloy and coated with HA. Primary fixation is with two to five titanium screws, secondary fixation through HA. - PE inserts available in flat-rim, anti-dislocation and reorientation.
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    K Number
    K962233
    Device Name
    TWIST-OFF SCREW
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1996-10-03

    (114 days)

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

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TWIST-OFF™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions.
    Device Description
    The TWIST-OFF™ SCREW is a threaded Titanium bone fixation appliance intended to be implanted. It is composed of a self-tapping, selfcompressive screw and support as a single piece. These two components separate when the screw head comes in contact with the cortex. Screws come in lengths of 11,12,13 and 14 mm; the support does not vary in size.
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    K Number
    K962236
    Device Name
    SCARF THREAD-HEAD SCREW
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1996-09-20

    (101 days)

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

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SCARF THREAD-HEAD™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions. The SCARF THREAD-HEAD™ SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
    Device Description
    The SCARF THREAD-HEAD™ SCREW is a cannulated thread-head screw made of a Titanium alloy. Screws come in lengths of 10-32 mm in 2 mm increments.
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    K Number
    K960642
    Device Name
    NANCY NAIL
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1996-05-17

    (93 days)

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

    LANDOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the 450mm it's is as a temporary ant to aid in the healing of lor fractures. I for children abo 110 130 ow 65 The 100mm Nancy Nail™ for small long bone with a long diaphysis. as carpal or tarsal bone
    Device Description
    The I fancy Nail™ is a titanium alloy pin, available in two lengths: 450mm and 100mm The 450mm is available in five diameters: 2.0, 2.5, 3.0, 3.5, 4.0. The 100mm has a diameter of 1mm
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