Device Classification Name |
Posterior Metal/Polymer Spinal System, Fusion
|
510(k) Number |
K060638 |
Device Name |
DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS |
Applicant |
ZIMMER SPINE, INC |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2027
|
|
Applicant Contact |
TIM CRABTREE |
Correspondent |
ZIMMER SPINE, INC |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2027
|
|
Correspondent Contact |
TIM CRABTREE |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 03/10/2006 |
Decision Date | 04/06/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|