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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Femoral, Resurfacing
510(k) Number K892398
Device Name BIPOLAR HIP SYSTEM
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 Number888.3400
Classification Product Code
KXA  
Date Received04/07/1989
Decision Date 05/23/1989
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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