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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K060428
Device Name CSS CANNULATED SCREW SYSTEM
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1815 W. MARKET
AKRON,  OH  44313
Applicant Contact LEE A STRNAD
Correspondent
ORTHOHELIX SURGICAL DESIGNS, INC.
1815 W. MARKET
AKRON,  OH  44313
Correspondent Contact LEE A STRNAD
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received02/21/2006
Decision Date 03/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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