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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 K090779
Device Name ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
Applicant
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD,  CA  92008
Applicant Contact CHERYL ALLEN
Correspondent
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD,  CA  92008
Correspondent Contact CHERYL ALLEN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received03/23/2009
Decision Date 07/07/2009
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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