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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K161363
Device Name Arsenal Spinal Fixation System
Applicant
ALPHATEC SPINE, INC
5818 el camino real
carlsbad,  CA  92008
Applicant Contact renee murphy
Correspondent
ALPHATEC SPINE, INC
5818 el camino real
carlsbad,  CA  92008
Correspondent Contact renee l. murphy
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI   OSH  
Date Received05/17/2016
Decision Date 06/10/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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