ACCULIF TL-PEEK IBF CAGE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K112095
Device Name ACCULIF TL-PEEK IBF CAGE
Applicant
COALIGN INNOVATIONS, INC.
1331 h street nw
12th floor
washington, 
DC 
20005

Applicant Contact justin eggleton
Correspondent
COALIGN INNOVATIONS, INC.
1331 h street nw
12th floor
washington, 
DC 
20005

Correspodent Contact justin eggleton
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 07/22/2011
Decision Date 12/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No