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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
Applicant Contact DOUGLAS W STUART
Correspondent
TURNKEY INTERGRATION USA, INC.
8021 KNUE RD.
SUITE 121
INDIANAPOLIS,  IN  46250
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3330
Classification Product Code
KWA  
Date Received05/09/1990
Decision Date 08/22/1990
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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