NUVASIVE SAGE LATERAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K121815
Device Name NUVASIVE SAGE LATERAL PLATE 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 888.3060
Classification Product Code
KWQ  
Date Received 06/20/2012
Decision Date 10/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No