Device Classification Name |
Posterior Metal/Polymer Spinal System, Fusion
|
510(k) Number |
K101704 |
Device Name |
ZIMMER DTO PIN PRESS INSTRUMENT |
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 | 888.3070
|
Classification Product Code |
|
Date Received | 06/17/2010 |
Decision Date | 08/18/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|