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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, Cement Restrictor
510(k) Number K020344
Device Name RPX TITANIUM CEMNT RESTRICTOR
Applicant
Sulzer Spine-Tech
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact ANGELA BYLAND
Correspondent
Sulzer Spine-Tech
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact ANGELA BYLAND
Regulation Number878.3300
Classification Product Code
JDK  
Date Received02/01/2002
Decision Date 05/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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