VIPER SYSTEMS


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111571
Device Name VIPER SYSTEMS
Applicant
JOHNSON & JOHNSON
325 paramount dr.
raynham, 
MA 
02767 -0151

Applicant Contact daphney germain-kolawole
Correspondent
JOHNSON & JOHNSON
325 paramount dr.
raynham, 
MA 
02767 -0151

Correspodent Contact daphney germain-kolawole
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 06/06/2011
Decision Date 07/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No