ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080615
Device Name ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)
Applicant
TITAN SPINE, LLC
10520 baehr rd
mequon, 
WI 
53092

Applicant Contact kevin gemas
Correspondent
TITAN SPINE, LLC
10520 baehr rd
mequon, 
WI 
53092

Correspodent Contact kevin gemas
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 03/04/2008
Decision Date 06/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No