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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 K051023
Device Name TOPEZ TOTAL ANKLE REPLACEMENT
Applicant
Topez Orthopedics, Inc.
4655 Kirkwood Ct.
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
Topez Orthopedics, Inc.
4655 Kirkwood Ct.
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number888.3110
Classification Product Code
HSN  
Date Received04/22/2005
Decision Date 11/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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