Exactech Vantage Total Ankle System

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

EXACTECH INC

The following data is part of a premarket notification filed by Exactech Inc with the FDA for Exactech Vantage Total Ankle System.

Pre-market Notification Details

• Device ID: K152217
• 510k Number: K152217
• Device Name: Exactech Vantage Total Ankle System
• Classification: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
• Applicant: EXACTECH INC 2320 NW 66TH COURT Gainesville, FL 32653
• Contact: Shing Jen Tai
• Correspondent: Shing Jen Tai; EXACTECH INC 2320 NW 66TH COURT Gainesville, FL 32653
• Product Code: HSN
• CFR Regulation Number: 888.3110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-07
• Decision Date: 2016-03-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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