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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 K152903
Device Name REVIVAL(TM) Modular Revision Hip Stem
Applicant
Corin USA
5670 W Cypress St.
Tampa,  FL  33607
Applicant Contact DIANA L. NADER-MARTONE
Correspondent
Corin USA
5670 W Cypress St.
Tampa,  FL  33607
Correspondent Contact DIANA L. NADER-MARTONE
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received10/01/2015
Decision Date 04/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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