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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 K902111
Device Name MODIFIED FREEMAN REVISION ACETABULAR CUP
Original Applicant
TURNKEY INTERGRATION USA, INC.
8021 knue rd.
suite 121
indianapolis,  IN  46250
Original Contact douglas w stuart
Regulation Number888.3330
Classification Product Code
KWA  
Date Received05/09/1990
Decision Date 08/22/1990
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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