DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM

• K Number: K974817
• Device Name: DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
• Manufacturer: DOCTOR'S RESEARCH GROUP, INC.
• Date Cleared: 1998-03-13 ( 80 days)
• Product Code: DZL
• Regulation Number: 872.4880
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The DRG MF Ti Alloy Bone screws are intended for craniofacial and mandibular trauma and reconstruction.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (DRG MF Titanium (Ti) Alloy Bone Screws). It does not contain any information about acceptance criteria, study details, performance data, or ground truth establishment. Therefore, I cannot fulfill your request to describe these elements based on the given input.

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.