DEVEX MESH SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K023835
Device Name DEVEX MESH SYSTEM
Original Applicant
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Original Contact karen f jurczak
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 11/18/2002
Decision Date 01/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No