(94 days)
The intended use of the Normed Transport Distraction Device is described and is identical to the 510 (k) number K990140 in which, the Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Transport Distraction Device. This Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are as follows: - Tumor Resections - Severe trauma which make continuous bone segments no longer possible . - Bone grafting defects . - Sever open mandibular fractures . - Facial deformity corrections
External Mandibular Fixator and/or Distractor
This FDA 510(k) summary does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The document is a notification for an additional distributor (Osteomedics® Inc.) for a device (Normed Bone Transport Distraction Device) that was previously cleared under 510(k) number K990140. It explicitly states that "The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling', quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K990140."
Therefore, none of the requested information can be extracted from the provided text. To obtain this information, one would need to refer to the original 510(k) submission (K990140) for the Normed Bone Transport Distraction Device.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.