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510(k) Data Aggregation

    K Number
    K151818
    Device Name
    SImmetry Sacroiliac Joint Fusion System
    Manufacturer
    Zyga Technology, Inc.
    Date Cleared
    2015-08-05

    (30 days)

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

    Zyga Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SImmetry® Sacroiliac Joint Fusion is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged partially threaded or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm-14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm-110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm-14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).
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    K Number
    K141549
    Device Name
    SImmetry Sacroiliac Joint Fusion System
    Manufacturer
    Zyga Technology, Inc.
    Date Cleared
    2015-01-15

    (218 days)

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

    Zyga Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged lag or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm - 14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm- 110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm - 14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).
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    K Number
    K130092
    Device Name
    SIMMETRY SACROILIAC JOINT FUSION SYSTEM
    Manufacturer
    Zyga Technology, Inc.
    Date Cleared
    2013-02-27

    (43 days)

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

    Zyga Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac ioint disruptions and degenerative sacroiliitis.
    Device Description
    The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws.
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    K Number
    K111801
    Device Name
    SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
    Manufacturer
    Zyga Technology, Inc.
    Date Cleared
    2011-07-21

    (24 days)

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

    Zyga Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SImmetry™ Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
    Device Description
    The SImmetry™ Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for use with the 6.5mm diameter screws.
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    K Number
    K110512
    Device Name
    SIMMETRY SACROILIAC JOINT FUSION SYSTEM
    Manufacturer
    Zyga Technology, Inc.
    Date Cleared
    2011-03-23

    (28 days)

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

    Zyga Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
    Device Description
    The SImmetryTM Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws. The revised surgical technique manual for the new modified version of the SImmetry™ Sacroiliac Joint Fusion System contain instructions for adding autologous graft material to the sacroiliac joint to help ensure fusion.
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    K Number
    K102907
    Device Name
    SIMMETRY SACROILIAC JOINT FUSION SYSTEM
    Manufacturer
    Zyga Technology, Inc.
    Date Cleared
    2010-12-14

    (74 days)

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

    Zyga Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
    Device Description
    The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm.
    Ask a Question

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