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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, Semi-Constrained (Metal Uncemented Acetabular Component)
510(k) Number K882675
Device Name ATH METAL:UHMWPE TOTAL HIP SYSTEM
Applicant
Kinamed, Inc.
10780 Santa Monica Blvd.,
Suite 100
Los Angeles,  CA  90025
Applicant Contact OETTE
Correspondent
Kinamed, Inc.
10780 Santa Monica Blvd.,
Suite 100
Los Angeles,  CA  90025
Correspondent Contact OETTE
Regulation Number888.3330
Classification Product Code
KWA  
Date Received06/28/1988
Decision Date 08/19/1988
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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