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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K051704
Device Name MYKRES SPINAL SYSTEM
Applicant
Showa Ika Kohgyo Co., Ltd.
11234 El Camino Real, Suite 20
San Diego,,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
Showa Ika Kohgyo Co., Ltd.
11234 El Camino Real, Suite 20
San Diego,,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received06/24/2005
Decision Date 07/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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