Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K183056 |
Device Name |
ASSURE® Anterior Cervical Plate System |
Applicant |
Globus Medical, Inc. |
Valley Forge Business Center |
2560 General Armistead Avenue |
Audubon,
PA
19403
|
|
Applicant Contact |
Kelly J. Baker |
Correspondent |
Globus Medical, Inc. |
Valley Forge Business Center |
2560 General Armistead Avenue |
Audubon,
PA
19403
|
|
Correspondent Contact |
Kelly J. Baker |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 11/02/2018 |
Decision Date | 04/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|