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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 Cemented Acetabular Component)
510(k) Number K896614
Device Name S.A.F. ACETABULAR CUP WITH POROUS COATING
Applicant
Synergy Orthopaedics Intl., Inc.
5780 W. 71st St.
Indianapolis,  IN  46278
Applicant Contact KENNETH EPLING
Correspondent
Synergy Orthopaedics Intl., Inc.
5780 W. 71st St.
Indianapolis,  IN  46278
Correspondent Contact KENNETH EPLING
Regulation Number888.3320
Classification Product Code
JDL  
Date Received11/21/1989
Decision Date 01/09/1990
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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