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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 K060132
Device Name SPINAL USA CEMENT RESTRICTOR SYSTEM
Applicant
Spinal USA
213 Eastside Ln.
Brandon,  MS  39047
Applicant Contact JEFFREY JOHNSON
Correspondent
Spinal USA
213 Eastside Ln.
Brandon,  MS  39047
Correspondent Contact JEFFREY JOHNSON
Regulation Number878.3300
Classification Product Code
JDK  
Date Received01/18/2006
Decision Date 03/16/2006
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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