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510(k) Data Aggregation

    K Number
    K100916
    Device Name
    MEDICON MOGEN CLAMP
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2010-12-06

    (248 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicon Mogen Circumcision Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant or child.
    Device Description
    The Medicon Mogen Circumcision Clamp is a stainless steel, reusable circumcision clamp consisting out of multiple components, including clamp and locking bar. For safety reasons the lock screw of the clamp is fixed with a spot welding point in order not to become loose. For safety reasons the clamp opens to a maximum of 2.5 mm, in order not to trap the glans and the edges of closing area are chamfered and rounded inside and outside to avoid injuries
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    K Number
    K083803
    Device Name
    FIXIT HEADREST CLAMP SYSTEM
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2010-03-10

    (443 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicon FIXIT head rest system is designed to provide stabilization and rigid fixation of patient's skull during surgical operations. It is indicated for neurosurgical operative procedures.
    Device Description
    The Medicon Fixit Head Rest System is made from one part, not 2 parts as the competitors systems. The Medicon clamp is designed to prevent closing by accident. The pistol handle with safety lock allows the surgeon a one-hand-use of the clamp. Furthermore, the movable parts are reduced to a minimum. The locking mechanism can be loaded with more than 90 kg. There is a variety of pin holders available. The choice of pin holders very much depends on the preference of the surgeon, the clinical indication and the type of position of the skull. The pins are made from Titanium and stainless steel and are delivered nonsterile. The pins are re-usable. At the pistol grip side there is a pressure indicator. By turning the screw the surgeon fixes the skull with a fineadjustment. Hydraulicus allows via a foot pedal to open and close the connector between the head rest clamp and the operating table which enables the surgeon to manipulate the head rest and / or the patient's head manually and at the same time open and close the locking mechanism with the foot peal. The base unit is connected to the operating table. As the base unit is equipped with a quick coupling, it may be adapted easily and fast to any operating table.
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    K Number
    K053624
    Device Name
    MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2006-07-17

    (201 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicon Stern-a-Fix Sternal Closure System is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
    Device Description
    The Medicon Stern-a-Fix Stermal Closure System consists of titanium plates and 2.4 mm locking and standard bone screws, as well as 2.7 mm emergency screws. All 2.4 mm screws are self- drilling, i.e., a predrilled hole is not required, but may be used if desired. Screws are provided in lengths from 7-15 mm. The plates are affixed to the sternum using the screws. They include thinner horizontal sections to facilitate quick re-entry.
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    K Number
    K050478
    Device Name
    MEDICON IMF-ORION SCREWS
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2005-06-15

    (111 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicon IMF Orion Screws are intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla, mandible or both.
    Device Description
    The MEDICON IMF-Orion Screws are available in different lengths. Threadlengths within the range of 10.0, 12.0, 14.0 mm and 16.0 mm. The diameter of the shafts is 2.0 mm. The head shape is in a diameter of 4.0 mm. It is grooved for fastening of wires and rubber bands. For a self-retaining fit to the blade the top is tapered inner hexagonal. The screws are manufactured of Ti6Al-4V according to ASTM F 136-02a. The MEDICON IMF-Orion Screws provide temporary occlusal and fracture stabilization which can be achieved within a matter of minutes. These screws may be applied prior to or after exposure of the fracture.
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    K Number
    K043297
    Device Name
    MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2005-02-23

    (86 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.
    Device Description
    The Medicon 2.4 Mandibular Reconstruction Plating System includes titanium plates, titanium alloy Star*Grip screws, templates and accompanying instruments and accessories. Plates are 2.5 mm thick and include flat and preformed straight, angled, and full mandible configurations in lengths from 6 screw holes to 29 screw holes. Plates can accept 2.4 mm diameter locking screws or standard, non-locking 2.4 mm and 2.7 mm diameter bone screws. All screws are self-tapping. The 2.7 mm diameter screws can also be used as emergency screws. The device is supplied non-sterile and must be sterilized prior to use. Moist heat sterilization is recommended. Instruments and accessories available are: screwdrivers, screw holding forceps, twist drills, drill guide, cheek retractor with drill guide and trocar, plate bender, plate bending forceps, plate bending pliers, cutting lever, plate holding forceps, plate cutting forceps, tap, templates, storage and sterilization trays for implants and instruments.
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    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?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    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
    K041527
    Device Name
    AARHUS ANCHORAGE SYSTEM
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2004-08-19

    (72 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aarhus Anchorage System is intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
    Device Description
    The Aarhus Anchorage System consists of 9.6 mm to 12.2 mm in length, non-sterile, single-use titanium screws designed to aid in dental movement by providing a rigid skeletal fixation point. The "self-drilling" thread design allows for easy insertion and removal - with the use of the system`s Grip Screwdriver Replaceable F Aarhus Screw Octagonal and Blades.
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    K Number
    K010908
    Device Name
    MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2001-08-01

    (128 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010910
    Device Name
    MEDICON YASARGIL CLIP APPLYING FORCEPS
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2001-08-01

    (128 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K972857
    Device Name
    SERVOTRONIC EC100 SYSTEM
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    1998-01-16

    (168 days)

    Product Code
    HBC
    Regulation Number
    882.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON, E.G.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Servotronic EC 100 System is intended to be used for high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in microsurgical procedures including maxillofacial surgery, ENT surgery, orthopedic surgery, plastic surgery, dental surgery and neurosurgery.
    Device Description
    The Servotronic EC 100 System's primary components are: (1) a control unit with irrigation pump; (2) a micromotor; (3) a foot switch for remote control; and (4) various hand pieces and tools. The hand pieces to be used with the Servotronic EC 100 System include the following: (1) Sachse Micro Oscillating Saw; (2) Sachse Micro Osseoscalpel Saw; (3) Micro Compass Saw; (4) Steinhauser Mucotome; (5) Micro Sagittal Saw; and (6) Hauenstein Angular Screwing Instrument. The Servotronic EC 100 requires an AC current of 110V or 230/240V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is connected to the back of the control unit. The Servotronic EC 100 has integrated safety and monitoring functions for excess temperature, current limitations within the main supply circuit and within the motor electronics, and a speed-dependent stop used during a change of direction.
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