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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 K991052
Device Name FS 1000 KNEE SYSTEM
Applicant
Renaissance Instruments, LLC
370 Ninth Ave., Suite 205
Salt Lake City,  UT  84103
Applicant Contact KENT M SAMUELSON
Correspondent
Renaissance Instruments, LLC
370 Ninth Ave., Suite 205
Salt Lake City,  UT  84103
Correspondent Contact KENT M SAMUELSON
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/30/1999
Decision Date 11/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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