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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K123705
Device Name TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
Applicant
CORIN USA
5670 W. CYPRESS ST.
SUITE C
TAMPA,  FL  33607
Applicant Contact DIANA L MARTONE
Correspondent
CORIN USA
5670 W. CYPRESS ST.
SUITE C
TAMPA,  FL  33607
Correspondent Contact DIANA L MARTONE
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received12/03/2012
Decision Date 02/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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