EVOLVE MODULAR RADIAL HEAD

Prosthesis, Elbow, Hemi-, Radial, Polymer

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Evolve Modular Radial Head.

Pre-market Notification Details

• Device ID: K060731
• 510k Number: K060731
• Device Name: EVOLVE MODULAR RADIAL HEAD
• Classification: Prosthesis, Elbow, Hemi-, Radial, Polymer
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Contact: Wesley L Reed
• Correspondent: Wesley L Reed; WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Product Code: KWI
• CFR Regulation Number: 888.3170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-20
• Decision Date: 2006-04-19
• Summary: summary

NIH GUDID Devices

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