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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, Hemi-, Femoral, Metal
510(k) Number K931753
Device Name CORIN THOMPSON PROSTHESIS, MODIFICATION
Applicant
Corin Orthopedic Products
10500 University Center Dr.
Suite 130
Tampa,  FL  33612
Applicant Contact JACK THOMAS
Correspondent
Corin Orthopedic Products
10500 University Center Dr.
Suite 130
Tampa,  FL  33612
Correspondent Contact JACK THOMAS
Regulation Number888.3360
Classification Product Code
KWL  
Date Received04/08/1993
Decision Date 10/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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