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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 K903938
Device Name C FIT CUP
Applicant
Orthopedic Systems, Inc.
C/O Surgical Implants, Inc.
6535 E. 82nd St., Suite 202
Indianapolis,  IN  46250
Applicant Contact DOUGLAS W STUART
Correspondent
Orthopedic Systems, Inc.
C/O Surgical Implants, Inc.
6535 E. 82nd St., Suite 202
Indianapolis,  IN  46250
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3350
Classification Product Code
JDI  
Date Received08/27/1990
Decision Date 01/04/1991
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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