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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 K902110
Device Name MODIFIED FREEMAN 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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