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510(k) Data Aggregation

    K Number
    K093046
    Device Name
    ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Date Cleared
    2011-03-22

    (538 days)

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

    SYNVASIVE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The eLIBRA® Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee replacement. The unit displays a number from 0-19 for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). The force sensor is sterile, for single patient use.
    Device Description
    The device consists of two units, the force sensing unit and an electronic display. The eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee Replacement is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The eLIBRA Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Force Sensing Unit. The unit displays a number from 0-19 for both the for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). Each number is equivalent to 0.5 pounds of force.
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    K Number
    K070108
    Device Name
    ELIBRA DYNAMIC KNEE BALANCER
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Date Cleared
    2007-04-04

    (83 days)

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

    SYNVASIVE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.
    Device Description
    The device consists of two units, the force sensing unit and an electronic display. The eLIBRATM Force Sensing Tibial Unit is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The electronic signal represents the relative medial and lateral compartment forces generated from the soft tissue structures surrounding the knee joint during a total knee arthroplasty (TKA). The LIBRA Dynamic Knee Balancer eLIBRATM Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRATM Force Sensing Tibial Unit. The unit displays a number from 0-19 for both the medial and lateral compartments in the knee joint to aid the surgeon in balancing soft tissue structures during a total knee arthroplasty (TKA).
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    K Number
    K972508
    Device Name
    SURGICAL BURS AND SURGICAL DRILL BITS
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Date Cleared
    1997-08-26

    (54 days)

    Product Code
    HWE
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNVASIVE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use of the surgical bur and surgical drill bit devices are situations in surgical procedures where bone, hard tissue, or soft tissue is drilled, reamed, sculpted, augmented, reduced, replaced, or removed.
    Device Description
    The subject devices (surgical burs and surgical drill bits) are stainless steel and/or tungsten carbide devices which may be coated with abrasion resistant coatings in order to increase cutting efficiency. They will be supplied as both sterile and non-sterile devices and will be labeled for single use.
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    K Number
    K961522
    Device Name
    KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Date Cleared
    1996-09-23

    (154 days)

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

    SYNVASIVE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.
    Device Description
    The subject devices (K-Wires and Steinmann Pins) are stainless steel fixation devices which draw bone fraqments together in order to facilitate healing. They will be supplied both as sterile and non-sterile devices and will be labeled for single use.
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