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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 K902074
Device Name KINAMED CEMENTED CTH STEM
Applicant
Kinamed, Inc.
2192-C Anchor Ct.
Newbury Park,  CA  91320
Applicant Contact CLARKE, PH.D.
Correspondent
Kinamed, Inc.
2192-C Anchor Ct.
Newbury Park,  CA  91320
Correspondent Contact CLARKE, PH.D.
Regulation Number888.3353
Classification Product Code
LZO  
Date Received05/07/1990
Decision Date 06/08/1990
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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