SKYLINE ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K103491
Device Name SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
Applicant
A JOHNSON & JOHNSON COMPANY
325 paramount drive
raynham, 
MA 
02767

Applicant Contact frank s jurczak
Correspondent
A JOHNSON & JOHNSON COMPANY
325 paramount drive
raynham, 
MA 
02767

Correspodent Contact frank s jurczak
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 11/26/2010
Decision Date 02/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No