INVISION Total Ankle Revision System

Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

Wright Medical Technology, Inc.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Invision Total Ankle Revision System.

Pre-market Notification Details

• Device ID: K153008
• 510k Number: K153008
• Device Name: INVISION Total Ankle Revision System
• Classification: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
• Applicant: Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
• Contact: Tara Conrad
• Correspondent: Tara Conrad; Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
• Product Code: HSN
• CFR Regulation Number: 888.3110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-10-14
• Decision Date: 2016-05-06
• Summary: summary

NIH GUDID Devices

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