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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 K901936
Device Name PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP
Applicant
Orthomet, Inc.
6301 Cecilia Cir.
Minneapolis,  MN  55439
Applicant Contact DENNIS H CRANE
Correspondent
Orthomet, Inc.
6301 Cecilia Cir.
Minneapolis,  MN  55439
Correspondent Contact DENNIS H CRANE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/30/1990
Decision Date 07/03/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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