INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K110045
Device Name INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
Applicant
VERTEBRAL TECHNOLOGIES, INC.
5909 baker road
suite 550
minnetonka, 
MN 
55345

Applicant Contact suresh ghai
Correspondent
VERTEBRAL TECHNOLOGIES, INC.
5909 baker road
suite 550
minnetonka, 
MN 
55345

Correspodent Contact suresh ghai
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 01/06/2011
Decision Date 02/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No