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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 K151459
Device Name Integra Total Ankle Replacement System
Applicant
Ascension Orthopedics
8700 Cameron Road, Suite 100
Austin,  TX  78754
Applicant Contact Frederic Testa
Correspondent
CoorsTek Medical
560 W. Golf Course Rd..
Providence,  UT  84332
Correspondent Contact Steve Brown
Regulation Number888.3110
Classification Product Code
HSN  
Date Received06/01/2015
Decision Date 08/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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