VUSION(R) OS


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K111965
Device Name VUSION(R) OS
Applicant
ORTHO DEVELOPMENT
12187 s. business park dr.
draper, 
UT 
84020

Applicant Contact tom haueter
Correspondent
ORTHO DEVELOPMENT
12187 s. business park dr.
draper, 
UT 
84020

Correspodent Contact tom haueter
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 07/11/2011
Decision Date 10/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No