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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 K121563
Device Name CORIN TRIFIT TS HIP
Applicant
CORIN USA
10500 UNIVERSITY CENTER DRIVE
SUITE 190
TAMPA,  FL  33612
Applicant Contact LUCINDA GERBER
Correspondent
CORIN USA
10500 UNIVERSITY CENTER DRIVE
SUITE 190
TAMPA,  FL  33612
Correspondent Contact LUCINDA GERBER
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWL   KWY   LZO  
Date Received05/29/2012
Decision Date 10/05/2012
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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