Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K061353 |
Device Name |
TRINICA ANTERIOR LUMBAR PLATE SYSTEM |
Applicant |
ZIMMER SPINE, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439
|
|
Applicant Contact |
TIM CRABTREE |
Correspondent |
ZIMMER SPINE, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439
|
|
Correspondent Contact |
TIM CRABTREE |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 05/15/2006 |
Decision Date | 08/30/2006 |
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
|
|
|