Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K121808 |
Device Name |
CASIAN, 3.5/4.5 CONNECTORS |
Applicant |
K2M, INC. |
751 MILLER DR.,SE |
LEESBURG,
VA
20175
|
|
Applicant Contact |
NANCY GIEZEN |
Correspondent |
K2M, INC. |
751 MILLER DR.,SE |
LEESBURG,
VA
20175
|
|
Correspondent Contact |
NANCY GIEZEN |
Regulation Number | 888.3050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/20/2012 |
Decision Date | 07/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|