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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 K922247
Device Name KINAMED REALITY TOTAL HIP SYSTEM
Applicant
Kinamed, Inc.
2192-C Anchor Ct.
Newbury Park,  CA  91320
Applicant Contact IAN C CLARKE
Correspondent
Kinamed, Inc.
2192-C Anchor Ct.
Newbury Park,  CA  91320
Correspondent Contact IAN C CLARKE
Regulation Number888.3353
Classification Product Code
LZO  
Date Received05/13/1992
Decision Date 03/30/1994
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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