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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 K201507
Device Name Cadence Total Ankle System
Applicant
Integra LifeSciences Corporation
11101 Metric Blvd.
Austin,  TX  78758
Applicant Contact Cassidy Lemkau
Correspondent
Integra LifeSciences Corporation
11101 Metric Blvd.
Austin,  TX  78758
Correspondent Contact Cassidy Lemkau
Regulation Number888.3110
Classification Product Code
HSN  
Date Received06/05/2020
Decision Date 06/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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