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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/polymer, cemented
510(k) Number K003666
Device Name TAPER-FIT TOTAL HIP SYSTEM
Applicant
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
tampa,  FL  33612
Applicant Contact joel k batts
Correspondent
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
tampa,  FL  33612
Correspondent Contact joel k batts
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LZO  
Date Received11/28/2000
Decision Date 02/08/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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