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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 K112285
Device Name MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE...
Applicant
Tgm Medical, Inc.
5145 Golden Foothill Pkwy.
Suite 175 & 180
El Dorado,  CA  95762
Applicant Contact DENNIS H CRANE
Correspondent
Tgm Medical, Inc.
5145 Golden Foothill Pkwy.
Suite 175 & 180
El Dorado,  CA  95762
Correspondent Contact DENNIS H CRANE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/09/2011
Decision Date 11/04/2011
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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