EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K103490
Device Name EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
Applicant
JOHNSON & JOHNSON
325 paramount dr.
raynham, 
MA 
02767 -0151

Applicant Contact kevin stevens
Correspondent
JOHNSON & JOHNSON
325 paramount dr.
raynham, 
MA 
02767 -0151

Correspodent Contact kevin stevens
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 11/26/2010
Decision Date 02/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No