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The Lorenz Distraction System includes devices intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction.

The Lorenz Distraction System includes several designs of implantable distractors which all have a drive screw mechanism and connection plates. Three basic types are included; without rails, with one rail, and with two rails. Each distractor is made of either Titanium or 316 LVM Stainless Steel materials.

This document is a 510(k) summary for the Lorenz Distraction System, and based on the provided text, it does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or multi-reader, multi-case studies.

The document primarily focuses on:

• Device Description: What the device is composed of and its various types.
• Intended Use: The medical conditions and anatomical areas the device is designed to treat.
• Potential Risks: General risks associated with the device and surgical procedures.
• Regulatory Information: FDA review and clearance details, including classification, general controls, and compliance requirements for marketing the device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The summary does not delve into the empirical data or studies that would demonstrate the device meets specific performance criteria.

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