Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K122021 |
Device Name |
STERISPINE LC CAGE |
Applicant |
SAFE ORTHOPAEDICS |
PARC DES BELLEVUES- ALLEE |
R LUXEMBOURG |
ERAGNY SUR OISE,
FR
95610
|
|
Applicant Contact |
P. DUMOUCHEL |
Correspondent |
SAFE ORTHOPAEDICS |
PARC DES BELLEVUES- ALLEE |
R LUXEMBOURG |
ERAGNY SUR OISE,
FR
95610
|
|
Correspondent Contact |
P. DUMOUCHEL |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 07/10/2012 |
Decision Date | 09/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|