Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K182406 |
Device Name |
Altus Spine Interbody Fusion System |
Applicant |
Altus Partners, LLC |
1340 Enterprise Drive |
West Chester,
PA
19380
|
|
Applicant Contact |
Mark Melton |
Correspondent |
Altus Partners, LLC |
1340 Enterprise Drive |
West Chester,
PA
19380
|
|
Correspondent Contact |
Mark Melton |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 09/04/2018 |
Decision Date | 02/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|