LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM

• K Number: K982906
• Device Name: LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
• Manufacturer: WALTER LORENZ SURGICAL, INC.
• Date Cleared: 1998-11-12 ( 86 days)
• Product Code: MQN
• Regulation Number: 872.4760
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Lorenz Intraoral Linear Mandibular Distraction System is intended for use in the gradual bone lengthening of the mandible as mandibular deficiencies or post traumatic defects require gradual bone distraction.

Device Description

Lorenz Intraoral Linear Mandibular Distraction System

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter from the FDA for the "Lorenz Intraoral Linear Mandibular Distraction System". This document does not contain information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment for an AI/ML powered medical device.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates a traditional medical device approval based on substantial equivalence to a predicate device, not an AI/ML driven device that would typically involve performance studies as outlined in your request.

Therefore, I cannot provide the requested information based on the provided text.

Regulation Number and Section

§ 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.