Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K073202 |
Device Name |
ARDIS SPACER |
Applicant |
ABBOTT SPINE, INC. |
5301 RIATA PARK CT., BLDG F |
AUSTIN,
TX
78727
|
|
Applicant Contact |
MARITZA ELIAS |
Correspondent |
ABBOTT SPINE, INC. |
5301 RIATA PARK CT., BLDG F |
AUSTIN,
TX
78727
|
|
Correspondent Contact |
MARITZA ELIAS |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/13/2007 |
Decision Date | 01/30/2008 |
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
|
|
|