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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 intervertebral body
510(K) Number K122910
Device Name ARCHON ANTERIOR CERVICAL PLATE SYSTE,
Applicant
NUVASIVE, INCORPORATED
7475 lusk boulevard
san diego,  CA  92121
Contact cynthia adams
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/21/2012
Decision Date 10/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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