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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K101206
Device Name TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
Applicant
Alexandria Research Technologies, LLC
13755 First Ave. N.
Suite 100
Plymouth,  MN  55441
Applicant Contact MICHAEL LARSON
Correspondent
Alexandria Research Technologies, LLC
13755 First Ave. N.
Suite 100
Plymouth,  MN  55441
Correspondent Contact MICHAEL LARSON
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Code
HRY  
Date Received04/30/2010
Decision Date 07/23/2010
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
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