NUVASIVE POLYAXIAL SPINAL SCREWS


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K121619
Device Name NUVASIVE POLYAXIAL SPINAL SCREWS
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 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 06/01/2012
Decision Date 08/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No