Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K130977 |
Device Name |
SIGNIFY BIOACTIVE |
Applicant |
GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. |
AUDUBON,
PA
19403
|
|
Applicant Contact |
SARAH MARIE FITZGERALD |
Correspondent |
GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. |
AUDUBON,
PA
19403
|
|
Correspondent Contact |
SARAH MARIE FITZGERALD |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 04/09/2013 |
Decision Date | 12/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|