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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, cervical
510(k) Number K110442
Device Name NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM
Applicant
NANOVIS, LLC
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact kevin a thomas, phd
Correspondent
NANOVIS, LLC
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact kevin a thomas, phd
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received02/16/2011
Decision Date 11/09/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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