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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 K053182
Device Name DRLOCK DISTAL RADIUS VOLAR SYSTEM
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
5905 FAWN LANE
CLEVELAND,  OH  44141
Applicant Contact EDWARD A KROLL
Correspondent
ORTHOHELIX SURGICAL DESIGNS, INC.
5905 FAWN LANE
CLEVELAND,  OH  44141
Correspondent Contact EDWARD A KROLL
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/14/2005
Decision Date 02/27/2006
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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