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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, porous uncemented
510(k) Number K103431
Device Name COREN TOTAL HIP SYSTEM
Applicant
CORENTEC CO., LTD
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact kevin a thomas
Correspondent
CORENTEC CO., LTD
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact kevin a thomas
Regulation Number888.3358
Classification Product Code
LPH  
Date Received11/23/2010
Decision Date 07/21/2011
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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