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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
Applicant
TURNKEY INTERGRATION USA, INC.
8021 knue rd.
suite 121
indianapolis,  IN  46250
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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