MODUS 2.5 MANDIBULAR TRAUMA SET

• K Number: K992683
• Device Name: MODUS 2.5 MANDIBULAR TRAUMA SET
• Manufacturer: MEDARTIS AG
• Date Cleared: 1999-11-24 ( 106 days)
• Product Code: JEY , JFY
• Regulation Number: 872.4760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K946165 , K950045 , K961421

Intended Use

The MODUS® 2.5 Trauma Set is intended for use in mandibular trauma fractures, e.g. in unstable, comminuted mandibular fractures and bone loss.

Device Description

The MODUS® 2.5 Mandibular Trauma Set is a complete fracture fixation system that includes titanium plates, titanium screws, templates, and accompanying instruments and accessories.

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device.

The document is a 510(k) summary for the MODUS® 2.5 Mandibular Trauma Set, which is a premarket notification to the FDA for a medical device. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance studies against specific acceptance criteria.

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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.