COPELAND RESURFACING HEADS

• K Number: K003044
• Device Name: COPELAND RESURFACING HEADS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2000-12-13 ( 75 days)
• Product Code: HSD
• Regulation Number: 888.3690
• 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

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.