NUVASIVE COROENT NO-PROFILE SYSTEM


Device Classification Name

intervertebral fusion device with integrated fixation, lumbar

510(k) Number K112561
Device Name NUVASIVE COROENT NO-PROFILE SYSTEM
Applicant
NUVASIVE, INC.
7475 lusk blvd
san diego, 
CA 
92121

Applicant Contact sheila bruschi
Correspondent
NUVASIVE, INC.
7475 lusk blvd
san diego, 
CA 
92121

Correspodent Contact sheila bruschi
Regulation Number 888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received 09/02/2011
Decision Date 03/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No