Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K120203 |
Device Name |
TM-400 DEVICE |
Applicant |
ZIMMER TRABECULAR METAL TECHNOLOGY, INC. |
10 POMEROY RD. |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
KATHLEEN RUTHERFORD |
Correspondent |
ZIMMER TRABECULAR METAL TECHNOLOGY, INC. |
10 POMEROY RD. |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
KATHLEEN RUTHERFORD |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/23/2012 |
Decision Date | 06/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|