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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
  View current 510(K) holder
Current 510(k) Holder *
CORIN MEDICAL, LTD.
THE CORINIUM CENTRE
cirencester,  UNITED KINGDOM  GL7 1YJ
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

 
* Reported through Establishment Registration and Device Listing
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