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K122591 Page 1 of 2 CLYDESDALE Spinal System 510(k) Summary August 2012 I. COMPANY: 11. CONTACT: Sp F 7 Medtronic Sophomore Dane USA, Inc 1800 Pyramid Place Memphis, Tennessee 38132 Becky Runner Regulatory

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What is clydesdale spinal system 510k?

The Clydesdale spinal system 510k is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed device.

Who is required to file clydesdale spinal system 510k?

Manufacturers of medical devices are required to file a Clydesdale spinal system 510k with the FDA before marketing the device.

How to fill out clydesdale spinal system 510k?

To fill out a Clydesdale spinal system 510k, manufacturers must provide information on the device's design, intended use, materials, performance data, and labeling.

What is the purpose of clydesdale spinal system 510k?

The purpose of a Clydesdale spinal system 510k is to demonstrate that a new medical device is as safe and effective as a legally marketed device that does not require premarket approval.

What information must be reported on clydesdale spinal system 510k?

Information that must be reported on a Clydesdale spinal system 510k includes device description, proposed labeling, indications for use, materials, performance testing, and summary of biocompatibility.

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