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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
Original Applicant
SYNERGY ORTHOPAEDICS INTL., INC.
5780 west 71st st.
indianapolis,  IN  46278
Original Contact kenneth epling
Regulation Number888.3330
Classification Product Code
KWA  
Date Received08/10/1989
Decision Date 12/01/1989
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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