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510(k) Data Aggregation

    K Number
    K151146
    Device Name
    N-Force Fixation System
    Manufacturer
    INNOVISION, INC.
    Date Cleared
    2015-07-24

    (86 days)

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

    INNOVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The N-Force Fixation System is intended for the fixation of bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver injectable bone void fillers to a surgical site.
    Device Description
    The N-Force Fixation System includes fully and partially cannulated screws in various diameters and lengths, in both fenestrated and non-fenestrated options. The system also includes washers and accompanying instruments. The N-Force Fixation System implants are made of titanium alloy.
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    K Number
    K132244
    Device Name
    N-FORCE FIXATION SYSTEM
    Manufacturer
    INNOVISION, INC.
    Date Cleared
    2014-03-06

    (231 days)

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

    INNOVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site: - . Beta-bsm (ETEX Corporation) - . CarriGen (ETEX Corporation)
    Device Description
    The N-Force Fixation System is a screw system fixation. It includes fully and partially cannulated screws in various diameters and lengths, and accompanying instruments. The N-Force Fixation System implants are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136. The N-Force Fixation System screws are cannulated and/or fenestrated and can be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.
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    K Number
    K102528
    Device Name
    N-FORCE FIXATION SYSTEM
    Manufacturer
    INNOVISION, INC.
    Date Cleared
    2011-07-28

    (328 days)

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

    INNOVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site: - . Beta-bsm (ETEX Corporation) - CarriGen (ETEX Corporation) .
    Device Description
    The N-Force Fixation System is a screw system for fracture fixation. It includes fully and partially cannulated screws in various lengths, and accompanying instruments. The N-Force Fixation System screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The N-Force Fixation System is cannulated and fenestrated which allow it to be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.
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    K Number
    K011914
    Device Name
    HYDRO2, HS-75
    Manufacturer
    INNOVISION, INC.
    Date Cleared
    2001-07-27

    (38 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The bifocal/multifocal designs of the HYDRO2 (filofocon A) contact lens are indicated for daily wear correction of visual acuity in non-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic. The lens may be disinfected with chemical disinfection only.
    Device Description
    Bifocal/Multifocal HYDRO2 (filofocon A) Daily Wear RGP Contact Lens
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    K Number
    K000485
    Device Name
    HYDRO2, HS-75
    Manufacturer
    INNOVISION, INC.
    Date Cleared
    2000-05-12

    (88 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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