EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K080191
Device Name EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM
Applicant
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact frank s jurczak
Correspondent
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact frank s jurczak
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 01/25/2008
Decision Date 04/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No