VU APOD INTERVERTABRAL BODY FUSION DEVICE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080822
Device Name VU APOD INTERVERTABRAL BODY FUSION DEVICE
Applicant
THEKEN SPINE LLC
1800 triplett blvd.
akron, 
OH 
44306

Applicant Contact dale davison
Correspondent
THEKEN SPINE LLC
1800 triplett blvd.
akron, 
OH 
44306

Correspodent Contact dale davison
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 03/24/2008
Decision Date 07/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls