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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 K895157
Device Name S.A.F. ACETABULAR CUP
Applicant
SYNERGY ORTHOPAEDICS INTL., INC.
5780 WEST 71ST ST.
INDIANAPOLIS,  IN  46278
Applicant Contact KENNETH EPLING
Correspondent
SYNERGY ORTHOPAEDICS INTL., INC.
5780 WEST 71ST ST.
INDIANAPOLIS,  IN  46278
Correspondent Contact KENNETH EPLING
Regulation Number888.3330
Classification Product Code
KWA  
Date Received08/10/1989
Decision Date 12/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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