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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854943
Device Name OMKNEE SYSTEM, POROUS COATED
Applicant
Orthomet, Inc.
4230 Trenton Ln.
Plymouth,  MN  55441
Applicant Contact A YOUNG
Correspondent
Orthomet, Inc.
4230 Trenton Ln.
Plymouth,  MN  55441
Correspondent Contact A YOUNG
Date Received12/10/1985
Decision Date 02/20/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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