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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 K100370
Device Name SYMMETRIC TOTAL KNEE AGUMENTS
Applicant
Signal Medical Corp.
1000 Des Peres Rd.
Suite 140
St. Louis,  MO  63131
Applicant Contact BRIAN KATERBERG
Correspondent
Signal Medical Corp.
1000 Des Peres Rd.
Suite 140
St. Louis,  MO  63131
Correspondent Contact BRIAN KATERBERG
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/12/2010
Decision Date 03/07/2011
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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