MODIFICATION TO VIPER SPINE SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K073562
Device Name MODIFICATION TO VIPER SPINE SYSTEM
Applicant
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact christopher klaczyk
Correspondent
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact christopher klaczyk
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 12/19/2007
Decision Date 05/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No