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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 K970346
Device Name PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT
Applicant
Kairos Orthopaedics
819 Striker Ave., Suite 10
Sacramento,  CA  95834
Applicant Contact BRIAN T CLEARY
Correspondent
Kairos Orthopaedics
819 Striker Ave., Suite 10
Sacramento,  CA  95834
Correspondent Contact BRIAN T CLEARY
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received01/30/1997
Decision Date 02/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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