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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, ankle, semi-constrained, cemented, metal/polymer
510(k) Number K183343
Device Name Vantage Total Ankle Flat Cut Talar Components
Exactech Inc
2320 NW 66th Court
Gainesville,  FL  32653
Applicant Contact Shing Jen Tai
Exactech Inc
2320 NW 66th Court
Gainesville,  FL  32653
Correspondent Contact Shing Jen Tai
Regulation Number888.3110
Classification Product Code
Date Received12/03/2018
Decision Date 04/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No