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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 K111811
Device Name BENDINI(TM) SPINAL ROD BENDING SYSTEM
Applicant
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO,  CA  92121
Applicant Contact Elias Ketchum
Correspondent
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO,  CA  92121
Correspondent Contact Elias Ketchum
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/27/2011
Decision Date 12/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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