MOUNTAINEER OCT SPINAL SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K080828
Device Name MOUNTAINEER OCT SPINAL SYSTEM
Applicant
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact lisa gilman
Correspondent
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact lisa gilman
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received 03/25/2008
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No