(54 days)
The KLS-Martin intra-oral distractor is intended to be used in the conditions of mandibular deficiency or post-traumatic effects of the mandible.
The KLS Martin Distractor device is designed to distract the mandible in cases of deficiency or post-traumatic effects of the mandible.
This document is a 510(k) summary for the KLS Intra-oral Mandibular Distractor. It describes the device, its intended use, and its substantial equivalence to a predicate device (KLS Distractor K973275).
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a regulatory submission for premarket notification (510(k)) to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. This type of submission relies on comparison to an existing device rather than presenting new performance data from specific studies with acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance studies.
§ 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.