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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 K894904
Device Name KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL
Applicant
Kinamed, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Applicant Contact J MANELLI
Correspondent
Kinamed, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Correspondent Contact J MANELLI
Regulation Number888.3353
Classification Product Code
LZO  
Date Received08/01/1989
Decision Date 03/19/1990
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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