TITANIUM CEMENT RESTRICTOR MATERIAL PEEK

• K Number: K010528
• Device Name: TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
• Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
• Date Cleared: 2001-10-10 ( 229 days)
• Product Code: JDK
• Regulation Number: 878.3300
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.