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510(k) Data Aggregation

    K Number
    K172907
    Device Name
    ELAN 4 Air Motor System
    Manufacturer
    Aesculap, Inc.
    Date Cleared
    2018-11-09

    (410 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELAN 4 Air Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
    Device Description
    The ELAN 4 Air Motor System is a pneumatic motor system that can be used with any sterile, pressurized gas (usually nitrogen). The system consists of several components such as wall adaptors, foot pedals, and handpieces. The foot pedal has the ability to connect various handpieces with integrated motors that contain attachments such as burrs, saw blades, and drills. The system allows for high-speed dissection at up to 80.000 RPM while also allowing low speed cutting between 1.000 and 20.000 RPM. The speed and rotation direction of the handpieces can be controlled via the foot pedal.
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    K Number
    K163182
    Device Name
    Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
    Manufacturer
    Medtronic Powered Surgical Solutions
    Date Cleared
    2017-03-23

    (129 days)

    Product Code
    HBB, DWH, EQJ, ERL, GET, HBE, HSZ, KFK
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. Additionally, the Pneumatic Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: - Lumbar Microdiscectomy - Lumbar Stenosis Decompression - Posterior Lumbar Interbody Fusion (PLIF) - Transforaminal Lumbar Interbody Fusion (TLIF) - Anterior Lumbar Interbody Fusion (ALIF) - Direct Lateral Interbody Fusion (DLIF)
    Device Description
    The Pneumatic Drill System is a pneumatically powered high-speed drill system consisting of a choice of various Pneumatic Handpieces (comprising of a High Pressure and Exhaust Hose, and Handpiece) equipped with a foot or finger controller, Pneumatic Foot Control Unit, Surgical Dissecting Tools, System Accessories, and where applicable, Attachments to support various Surgical Dissecting Tools, and System Accessories.
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    K Number
    K150801
    Device Name
    Stryker Maestro Air Motors
    Manufacturer
    STRYKER CORPORATION
    Date Cleared
    2015-05-22

    (57 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker® Consolidated Operating Room Equipment (CORE™) Maestro Air Pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting. tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial and sternotomy surgeries.
    Device Description
    The Stryker® Maestro Air™ Motor(s) is a pneumatic motor powered by a regulated gas source. When connected to a gas source via tubing, the pneumatic motor operates at a normal operating pressure up to 150-psi (per square inch). The motor speed is controlled by a handswitch or a footpedal that connects to the motor and to a regulated gas source.
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    K Number
    K101168
    Device Name
    LEGEND POWER ADAPTER MODEL: 6475000
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Date Cleared
    2010-08-24

    (120 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.
    Device Description
    The LEGEND® Power Adapter is a stainless steel adapter that can be used with the MIDAS REX® LEGEND® System to provide power to MEDTRONIC rotating surgical cutting tools. The LEGEND® Power Adapter provides a 20:1 gear ratio reduction when used with the MIDAS REX® LEGEND® System.
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    K Number
    K093361
    Device Name
    SYNTHES AIR PEN DRIVE (APD) SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2010-04-14

    (168 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synthes Air Pen Drive (APD) is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery
    Device Description
    The Synthes Air Pen Drive (APD) System is a pneumatic powered system that consists of a Foot Pedal, Drive Unit, Hand Switch and Irrigation Control Unit that may be used with various commercially available attachments and cutting tools. The Drive Unit is pen-shaped and is connected to the Foot Pedal via a sterilizeable air hose. The rotation speed of the Drive Unit may be controlled from 0 to 60,000 rpm at 8 bar and from 0 to 80,000 at 12 bar via the Foot Pedal or the removable Hand Switch. Multiple attachments are available that have a quick-connect coupling to attach to the Drive Unit. The attachments accept various cutting tools including drill bits, burrs and saw blades.
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    K Number
    K090112
    Device Name
    MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Date Cleared
    2009-03-26

    (69 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic Midas Rex MR7 System is a pneumatically operated surgical instrument system. The pneumatic motors provide power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
    Device Description
    The Midas Rex MR7 Pneumatic High Speed System includes a pneumatic motor; either the MR7 option which is foot controlled or the MR7t option which is finger controlled. A coaxial hose system, designed with an inner high-pressure supply hose located within an exhaust hose, connects the motor to the foot controller. One end of the coaxial hose system is permanently attached to the motor. The inner high-pressure hose supplies the compressed gas to the internal components of the motor. The outer hose captures the exhausted gas from the internal components of the motor and transports this exhaust gas to the diffuser section of the lubricant diffuser cartridge located on the foot control end of the hose at floor level. This self-contained lubricant/diffuser system consists of two components; a permanently attached receptor base on the foot control connector section of the hose and a disposable lubricant/diffuser cartridge. The cartridge provides two functions; the lubrication for the internal components of the motor and the capture of the exhausted gas from the motor. the foot or finger controller is used to activate the flow of compressed air or nitrogen (gas) into the pneumatic motor and is connected to the pressure regulator of the gas supply system through the regulator hose. The Midas Rex MR7 Pneumatic High Speed System is intended to be used with all existing Midas Rex Legend attachments and dissecting tools previously cleared through K020069.
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    K Number
    K061297
    Device Name
    ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Date Cleared
    2007-01-26

    (262 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anspach iMRI Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.
    Device Description
    The iMRI Surgical Drill System is a Class II medical device which includes a pneumatic drill motor and foot control; a variety of nosepiece attachments; and various bone dissection tools (cutters). To make the drill system "MRI useable", ferrous metals comprising each system component have been replaced with materials known to have significantly lower or no discernable magnetic susceptibility. The iMRI Drill System foot control was tested with the Drill System within Zone IV. The iMRI motor does not require continuous oiling and therefore runs at slower speeds (60 - 65k RPM) than noniMRI Anspach motors (80 - 85k RPM). Nosepiece attachments (bearing tubes) support the cutter to minimize vibration , wobble and whipping. iMRI cutters are identical to other Anspach non-iMRI cutters with exception of materials and indications for use.
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    K Number
    K061725
    Device Name
    STRYKER ARIA PNEUMATIC SYSTEM
    Manufacturer
    STRYKER INSTRUMENTS
    Date Cleared
    2006-10-26

    (129 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K042974
    Device Name
    MEDICON VIPAIR HIGH SPEED SYSTEM
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2005-01-13

    (77 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicon VIPAIR high speed system is specially designed for cutting and drilling of cranial and spinal bones in the Neurology. Thanks to a wide variety of working attachments and tools, the Medicon pneumatic high speed system "VIP AIR" can be also used in the ENT and Orthopaedics.
    Device Description
    The Medicon VIPAIR pneumatic high speed system is specially designed for cutting and drilling of cranial and spinal bones. This system combines security and precision in an ergonomic design. The latest technology allows a reduction of the noise level to a minimum. The System consists of a small handpiece motor, a motor air tube, a foot control, a wall air tube, various hand pieces, craniotoms , burs, drills and cutters. The system components connect to each other via a safety coupling mechanism.
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    K Number
    K041754
    Device Name
    STRYKER MAESTRO SYSTEM
    Manufacturer
    STRYKER CORP.
    Date Cleared
    2004-09-07

    (70 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Product Code :

    HBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Maestro Pneumatic system is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear, Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
    Device Description
    The Stryker Maestro Pneumatic System is a pneumatic, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories.
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