INBONE TOTAL ANKLE

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 Inbone Total Ankle.

Pre-market Notification Details

• Device ID: K133585
• 510k Number: K133585
• Device Name: INBONE TOTAL ANKLE
• Classification: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Contact: Val Myles
• Correspondent: Val Myles; WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Product Code: HSN
• CFR Regulation Number: 888.3110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-21
• Decision Date: 2014-02-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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