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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/Polymer, Cemented
510(k) Number K913874
Device Name INFINITY(TM) MICROTAPER HIP SYSTEM
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact MICKI ROY
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact MICKI ROY
Regulation Number888.3350
Classification Product Code
JDI  
Date Received08/29/1991
Decision Date 11/27/1991
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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