NUVASIVE NVJJB SYSTEM


Device Classification Name

stimulator, nerve

510(k) Number K112717
Device Name NUVASIVE NVJJB 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

Correspodent Contact elias ketchum
Regulation Number 874.1820
Classification Product Code
ETN  
Subsequent Product Codes
GWF   IKN  
Date Received 09/19/2011
Decision Date 04/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No