LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES

• K Number: K972322
• Device Name: LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
• Manufacturer: WALTER LORENZ SURGICAL, INC.
• Date Cleared: 1997-08-18 ( 59 days)
• Product Code: JEY
• Regulation Number: 872.4760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Rigid fixation of cranio, facial and neurological bone.

Device Description

The titanium bone plates and screws are manufactured in various sizes, with various design features for cranio, facial, and neurological surgical procedures.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Lorenz Sterile Bone Plates and Screws." This document does not describe:

• Acceptance criteria or device performance data. The letter merely states that the device is substantially equivalent to legally marketed predicate devices.
• Any specific study details. There is no mention of clinical trials, performance studies, sample sizes, expert involvement, or ground truth methodologies.

Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a technical report detailing product performance or study design.

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.