EXPEDIUM SYSTEM, VIPER SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K110216
Device Name EXPEDIUM SYSTEM, VIPER SYSTEM
Applicant
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact eugene bang
Correspondent
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact eugene bang
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 01/25/2011
Decision Date 04/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No