Device Classification Name |
intervertebral fusion device with bone graft, cervical
|
510(k) Number |
K191243 |
Device Name |
HEDRON Cervical Spacers |
Applicant |
Globus Medical Inc. |
2560 General Armistead Ave. |
Audubon,
PA
19403
|
|
Applicant Contact |
Kelly Baker |
Correspondent |
Globus Medical Inc. |
2560 General Armistead Ave. |
Audubon,
PA
19403
|
|
Correspondent Contact |
Kelly Baker |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/09/2019 |
Decision Date | 09/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|