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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 K103272
Device Name ZENIUS SPINAL SYSTEM
Applicant
Medyssey Co, Ltd.
6170 S. 380 W.
Suite 200
Murray,  UT  84107
Applicant Contact PATRICK MOORE
Correspondent
Medyssey Co, Ltd.
6170 S. 380 W.
Suite 200
Murray,  UT  84107
Correspondent Contact PATRICK MOORE
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWQ   MNH  
Date Received11/05/2010
Decision Date 12/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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