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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 K020836
Device Name RABEA CEMENT RESTRICTOR
Applicant
Signus Medical, LLC
4050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Applicant Contact ANN QUINLAN-SMITH
Correspondent
Signus Medical, LLC
4050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Correspondent Contact ANN QUINLAN-SMITH
Regulation Number878.3300
Classification Product Code
JDK  
Date Received03/14/2002
Decision Date 06/11/2002
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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