IMTEC/TITANIUM MESH

• K Number: K970841
• Device Name: IMTEC/TITANIUM MESH
• Manufacturer: IMTEC CORP.
• Date Cleared: 1997-04-30 ( 54 days)
• Product Code: JEY
• Regulation Number: 872.4760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K963394 , K862482 , K923491

Intended Use

Not Found

Device Description

The IMTEC/TitaniumMesh consists of a laser cut segment of precision expanded, flattened and annealed Titanium Mesh of a specific size dimension and pore dimension. The device will be marketed sterile.

AI/ML Overview

I apologize, but the provided text from the K970841 510(k) summary does not contain any information regarding clinical studies, device performance, acceptance criteria, ground truth, or sample sizes.

The document is a 510(k) summary that focuses on:

• Submission Information: Submitter's contact details, FDA registration, date of submission.
• Device Classification and Naming: Classification name, common name, proprietary name.
• Predicate Devices: A list of previously cleared devices to which the IMTEC/TitaniumMesh is substantially equivalent.
• Device Description: A brief physical description of the IMTEC/TitaniumMesh (laser cut, expanded, flattened, annealed titanium mesh of specific size/pore, marketed sterile).

Therefore, I cannot fulfill your request for the detailed information asked in your prompt based on the provided text. To answer your questions, I would need a section of the 510(k) addressing performance data, clinical testing, or evidence of substantial equivalence based on performance.

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.