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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 K854883
Device Name OMKNEE SYSTEM
Applicant
Orthomet, Inc.
4230 Trenton Ln.
Plymouth,  MN  55441
Applicant Contact KAREN YOUNG
Correspondent
Orthomet, Inc.
4230 Trenton Ln.
Plymouth,  MN  55441
Correspondent Contact KAREN YOUNG
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/06/1985
Decision Date 02/18/1986
Decision Substantially Equivalent (SESE)
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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