Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K121246 |
Device Name |
MEDYSSY LT CAGE SYSTEM |
Applicant |
MEDYSSEY CO., LTD. |
8001 N. LINCOLN AVE |
SKOKIE,
IL
60077
|
|
Applicant Contact |
MICHAEL KVITNISKY |
Correspondent |
MEDYSSEY CO., LTD. |
8001 N. LINCOLN AVE |
SKOKIE,
IL
60077
|
|
Correspondent Contact |
MICHAEL KVITNISKY |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 04/25/2012 |
Decision Date | 06/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|