BENDINI(TM) SPINAL ROD BENDING SYSTEM


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

Correspodent Contact elias ketchum
Regulation Number 882.4560
Classification Product Code
OLO  
Date Received 06/27/2011
Decision Date 12/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No