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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, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K093472
Device Name TRINITY ACETABULAR SYSTEM
Applicant
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA,  FL  33612
Applicant Contact ASHLEA BOWEN
Correspondent
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA,  FL  33612
Correspondent Contact ASHLEA BOWEN
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
LWJ   LZO  
Date Received11/06/2009
Decision Date 11/23/2010
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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