EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111136
Device Name EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
Applicant
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact frank jurczak
Correspondent
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact frank jurczak
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received 04/22/2011
Decision Date 06/14/2012
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls