FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The SODEM HIGH SPEED SYSTEM (with associated accessories/attachments) is intended for use for neurosurgery (spine and craniotomy) and median sternotomy.

Device Description

The SODEM HIGH SPEED SYSTEM is a modular, pneumatic, high speed instrument system consisting of a handpiece and accessories/attachments (including but not limited to adapter, spindles, and burrs).

AI/ML Overview

The provided text is a 510(k) summary for a medical device (SODEM High Speed System) and does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the provided questions. This type of document focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, sterility, energy consumption, and operational principles, rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials or software validation studies.

Therefore, I cannot extract the requested information from the given text.

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K Number

K955174

Device Name

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY

Manufacturer

SODEM DIFFUSION SA

Date Cleared

1996-01-22

(70 days)