X-MESH EXPANDABLE CAGE SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K080568
Device Name X-MESH EXPANDABLE CAGE SYSTEM
Applicant
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact hande tufan
Correspondent
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact hande tufan
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 02/29/2008
Decision Date 05/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No