Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K113561 |
Device Name |
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION |
Applicant |
ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
JUDITH ROSEN |
Correspondent |
ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
JUDITH ROSEN |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 12/01/2011 |
Decision Date | 05/29/2012 |
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
|
|
|