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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 K021719
Device Name FORTITUDE CEMENT RESTRICTOR
Applicant
Spinal Concepts, Inc.
12012 Technology Blvd., #100
Austin,  TX  78727
Applicant Contact DAVID M HOOPER
Correspondent
Spinal Concepts, Inc.
12012 Technology Blvd., #100
Austin,  TX  78727
Correspondent Contact DAVID M HOOPER
Regulation Number878.3300
Classification Product Code
JDK  
Date Received05/23/2002
Decision Date 08/15/2002
Decision SE - With Limitations (SESU)
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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