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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal interlaminal
510(K) Number K072081
Device Name ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
Applicant
ALPHATEC SPINE, INC.
2051 palomar airport road
suite 100
carlsbad,  CA  92011
Contact mary stanners
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received07/30/2007
Decision Date 10/24/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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