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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K061400
Device Name CALCANEAL TRAUMA SYSTEM
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1815 WEST MARKET ST.
SUITE 205
AKRON,  OH  44313
Applicant Contact LEE A STRNAD
Correspondent
ORTHOHELIX SURGICAL DESIGNS, INC.
1815 WEST MARKET ST.
SUITE 205
AKRON,  OH  44313
Correspondent Contact LEE A STRNAD
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/19/2006
Decision Date 06/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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