SPINEFRONTIER DORADO VBR


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K072289
Device Name SPINEFRONTIER DORADO VBR
Applicant
SPINEFRONTIER, INC.
100 cummings center
suite 240c
beverly, 
MA 
01915

Applicant Contact tom carlson
Correspondent
SPINEFRONTIER, INC.
100 cummings center
suite 240c
beverly, 
MA 
01915

Correspodent Contact tom carlson
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 08/16/2007
Decision Date 11/01/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No