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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 K031318
Device Name TRAXIS CEMENT RESTRICTOR
Applicant
Spinal Concepts, Inc.
5301 Riata Park Ct., Bldg. F
Austin,  TX  78727
Applicant Contact LISA PETERSON
Correspondent
Spinal Concepts, Inc.
5301 Riata Park Ct., Bldg. F
Austin,  TX  78727
Correspondent Contact LISA PETERSON
Regulation Number878.3300
Classification Product Code
JDK  
Date Received04/25/2003
Decision Date 08/22/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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