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510(k) Data Aggregation

    K Number
    K163308
    Device Name
    SMARTO
    Manufacturer
    JEIL MEDICAL CORPORATION
    Date Cleared
    2016-12-27

    (34 days)

    Product Code
    KIJ
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    KIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMARTO is intended for use in drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomnies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.
    Device Description
    The SMARTO is an DC-powered device that includes a hand-held motor, switch and hold for the rotation attachment for surgery. It is supplied radiation-sterile and disposable use.
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    K Number
    K112599
    Device Name
    INSURGICAL SINGLE USE POWER EQUIPMENT
    Manufacturer
    INSURGICAL LLC
    Date Cleared
    2012-11-06

    (426 days)

    Product Code
    KIJ
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    KIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Insurgical™ Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
    Device Description
    The Insurgical™ Single Use Power Equipment System includes surgical power tools and rechargeable batteries. The battery powered DC Motor products include the Insurgical Drill, and the Insurgical Orthopedic Reamer. Insurgical handpieces and attachments are provided pre-sterilized and ready to use. The powered DC Motor products and attachments are single-use and intended to be disposed of after use. The batteries can be recharged and are re-usable. The Insurgical Drill is designed for drilling holes and placing bone screws in a variety of reconstructive and trauma procedures. The Insurgical Orthopedic Reamer can be used for boring, drilling, and reaming during orthopedic procedures.
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    K Number
    K101563
    Device Name
    SMARTO
    Manufacturer
    JEIL MEDICAL CORPORATION
    Date Cleared
    2010-12-17

    (196 days)

    Product Code
    KIJ
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    KIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMARTO is used to drive screws, and drilling in conjunction with craniofacial (does not include maxillofacial applications), craniotomies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and is for single use only.
    Device Description
    The SMARTO is a sterile battery powered screwdriver. The device includes a DC motor, battery, switch and holder for the rotation attachment. It is disposable.
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    K Number
    K972367
    Device Name
    STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
    Manufacturer
    STRYKER INSTRUMENTS
    Date Cleared
    1997-09-04

    (71 days)

    Product Code
    KIJ
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    KIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker System 4000 Battery Powered Heavy Duty System is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
    Device Description
    The Stryker System 4000 is comprised of drills, a reamer, a rotary driver, saws, rechargeable batteries, battery chargers, a battery protector kit, sterilization cases and racks, and cutting accessories. The system is designed to meet the IEC 601.1 safety standards.
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    K Number
    K970378
    Device Name
    STRYKER 2115 REPLACEMENT BATTERY (2115)
    Manufacturer
    IMPLANT RESOURCE, INC.
    Date Cleared
    1997-04-30

    (89 days)

    Product Code
    KIJ
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    KIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960711
    Device Name
    ACUMED BONE GRAFT SYSTEM
    Manufacturer
    ACUMED, INC.
    Date Cleared
    1996-05-07

    (76 days)

    Product Code
    KIJ
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    KIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Acumed Bone Grafting System is a set of various size drills, a Hudson adaptor fitting, a starting punch, a bone plug extractor, and a removal key. A manual drill handle will be added to the system eventually so that the drills may be operated manually. The Hudson adaptor fitting attaches to a standard DC-powered surgical drill. The drill size is selected and attached to the adaptor. The starting punch dimples the bone so a reference point for the drill tip is made. After drilling and harvesting the bone, the drill assembly is removed. The drill piece is detached with the removal key and the bone material is extracted or pushed out by the plug extractor.
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