MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

• K Number: K994175
• Device Name: MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
• Manufacturer: SODEM SYSTEMS
• Date Cleared: 1999-12-21 ( 11 days)
• Product Code: HBB
• Regulation Number: 882.4370
• Type: Special
• Panel: NE
• Reference & Predicate Devices: K954717

Intended Use

The Sodem High Speed System (with associated accessories/attachments) is intended for use for neuro surgery (spine and craniatomy) and median sternotomy.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Sodem High Speed System. It does not contain information about acceptance criteria, detailed study designs, or performance metrics. Therefore, I cannot extract the requested information from the provided text.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing. It mentions "indications for use" and refers to general controls, but does not include specific efficacy or performance study details, acceptance criteria, or expert review processes.

Regulation Number and Section

§ 882.4370 Pneumatic cranial drill motor.

(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).