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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K130084
Device Name MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM
Applicant
Tgm Medical, Inc.
5145 Golden Foothill Pkwy.
Suite 175
El Dorado Hills,  CA  95762
Applicant Contact PRAKASH PAI
Correspondent
Tgm Medical, Inc.
5145 Golden Foothill Pkwy.
Suite 175
El Dorado Hills,  CA  95762
Correspondent Contact PRAKASH PAI
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/14/2013
Decision Date 05/03/2013
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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