SPINOUS PROCESS PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K073278
Device Name SPINOUS PROCESS PLATE SYSTEM
Applicant
NUVASIVE, INC.
4545 towne centre court
san diego, 
CA 
92121

Applicant Contact laetitia cousin
Correspondent
NUVASIVE, INC.
4545 towne centre court
san diego, 
CA 
92121

Correspodent Contact laetitia cousin
Regulation Number 888.3050
Classification Product Code
KWP  
Date Received 11/21/2007
Decision Date 03/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No