Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K113447 |
Device Name |
RISE SPACER |
Applicant |
GLOBUS MEDICAL, INC. |
2560 GENERAL ARMISTEAD AVE. |
VALLEY FORGE BUSINESS CENTER |
AUDUBON,
PA
19403
|
|
Applicant Contact |
KELLY J BAKER |
Correspondent |
GLOBUS MEDICAL, INC. |
2560 GENERAL ARMISTEAD AVE. |
VALLEY FORGE BUSINESS CENTER |
AUDUBON,
PA
19403
|
|
Correspondent Contact |
KELLY J BAKER |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/21/2011 |
Decision Date | 01/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|