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For the management of hypertrophic and keloid scars

The NewGel Plus introduced by NewMedical Technology, Inc., is a device which substantially equivalent to other marketed silicone gel sheets. Indications for use are substantially the same, that is, topical treatment of scars. The advantages over other marketed devices from other vendors include the size of the strips in the package to enhance ease of use. In summary, the features incorporated into the NewMedical NewGel Plus have specific advantages over other substantially equivalent products to enhance ease of placement/ application along with the care and comfort of the patient. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.

indicated for use for pediatric as well adult Metacarpal-Phalangeal fractures. For external fixation of hand fractures or for distraction of osteotomies for the purpose of distraction osteogenesis as fractures.

The micro distractor/external fixator introduced by NewMedical Technology, Inc., is a device which is substantially equivalent to other marketed external fixators /distractors. Its indications for use are substantially the same, that is, external fracture fixation and/or distraction. The NewMedical Micro Distractor/External Fixator described here is completely identical to the NewMedical Micro Bone Distractor/Fixator that has already been approved by the (FDA/Dental Devices Committee) for use in external fixation of mandibular fractures or for mandibular distraction, referring to NewMedical Technology, Inc. product (K030485). The main advantages over other marketed devices from other vendors include its' smaller profile and lightweight construction. The recessed distraction actuating screw is tamper resistant and hence better for use in pediatric patients. The device can only be actuated with the use of a custom actuator which is provided in the kit with the device. Hence, this tamper resistant design is useful when the device is used as an external bone fixation device for the treatment of fractures. Similarly, the conversion to a static from a dynamic fixator does not reguire any adjustment or addition of parts. The alloy metals used provide for excellent stability. In summary, the features incorporated into the NewMedical Micro Distractor/External Fixator have specific advantages over other substantially equivalent products to enhance ease of placement along with the care and comfort of the patient requiring external fixation/distraction of the mandible or small bones. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.

For pediatric patients, for external fixation of mandibular fractures or for mandibular distraction.

The micro distractor/external fixator introduced by NewMedical Technology, Inc., is a device which is substantially equivalent to other external fixators /distractors. Its indications for use are substantially the same, that is, external fracture fixation and/or distraction. There are many unique features that make this distractor an improvement over those currently available. The main advantages over other devices include its' smaller size and lightweight construction. The recessed distraction actuating screw is tamper resistant and hence better for use in pediatric patients. The device can only be actuated with the use of a custom actuator which is provided in the kit with the device. Hence, this tamper resistant design is useful when the device is used as an external bone fixation device for the treatment of fractures. Similarly, the conversion to a static from a dynamic fixator does not require any adjustment or addition of parts. The alloy metals used provide for excellent stability. In summary, the features incorporated into the NewMedical Micro Distractor/External Fixator have specific advantages over other substantially equivalent products to enhance ease of placement along with the care and comfort of the patient requiring external fixation/distraction of the mandible or small bones.