Device Classification Name |
Posterior Metal/Polymer Spinal System, Fusion
|
510(k) Number |
K092234 |
Device Name |
DYNESYS TOP-LOADING SPINAL SYSTEM |
Applicant |
ZIMMER SPINE, INC |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2027
|
|
Applicant Contact |
ELSA A LINKE |
Correspondent |
ZIMMER SPINE, INC |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2027
|
|
Correspondent Contact |
ELSA A LINKE |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 07/23/2009 |
Decision Date | 10/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|