Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, 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
|
|
Correspondent Contact |
DALE DAVISON |
Regulation Number | 888.3080
|
Classification Product Code |
|
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
|
|
|