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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic stereotaxic instrument
510(K) Number K122742
Device Name NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
Applicant
NUVASIVE, INC.
7475 lusk blvd
san diego,  CA  92121
Contact sheila bruschi
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/07/2012
Decision Date 12/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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