INFINITY TOTAL ANKLE 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 Infinity Total Ankle System.

Pre-market Notification Details

• Device ID: K123954
• 510k Number: K123954
• Device Name: INFINITY TOTAL ANKLE SYSTEM
• Classification: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Contact: Samir Ibrahim
• Correspondent: Samir Ibrahim; WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Product Code: HSN
• CFR Regulation Number: 888.3110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-21
• Decision Date: 2013-04-01
• Summary: summary

NIH GUDID Devices

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