SPINAL ELEMENTS BUTTRESS PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K081418
Device Name SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
Applicant
SPINAL ELEMENTS, INC.
2744 loker ave. w. suite 100
carlsbad, 
CA 
92008

Applicant Contact kerri dimartino
Correspondent
SPINAL ELEMENTS, INC.
2744 loker ave. w. suite 100
carlsbad, 
CA 
92008

Correspodent Contact kerri dimartino
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 05/20/2008
Decision Date 07/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No