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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 K903976
Device Name CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
Applicant
Kinamed, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Applicant Contact DANIEL MANELLI
Correspondent
Kinamed, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Correspondent Contact DANIEL MANELLI
Regulation Number888.3353
Classification Product Code
LZO  
Date Received08/28/1990
Decision Date 01/09/1991
Decision Substantially Equivalent (SESE)
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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