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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 K972995
Device Name THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM
Applicant
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Applicant Contact JACK THOMAS
Correspondent
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Correspondent Contact JACK THOMAS
Regulation Number888.3350
Classification Product Code
JDI  
Date Received08/12/1997
Decision Date 11/10/1997
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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