VU C*POD INTERVERTEBRAL BODY FUSION DEVICE


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K111675
Device Name VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
Applicant
THEKEN SPINE LLC
1153 medina rd.
medina, 
OH 
44256 -0000

Applicant Contact dale davison
Correspondent
THEKEN SPINE LLC
1153 medina rd.
medina, 
OH 
44256 -0000

Correspodent Contact dale davison
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 06/15/2011
Decision Date 08/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No