SPINEFRONTIER LUMBAR IBF SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K111553
Device Name SPINEFRONTIER LUMBAR IBF SYSTEM
Applicant
SPINEFRONTIER, INC.
500 cummings center, ste. 3500
beverly, 
MA 
01915

Applicant Contact hannah crowe
Correspondent
SPINEFRONTIER, INC.
500 cummings center, ste. 3500
beverly, 
MA 
01915

Correspodent Contact hannah crowe
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 06/03/2011
Decision Date 09/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No