Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K183560 |
Device Name |
Luna 3D GEN2 Interbody Fusion System |
Applicant |
Benvenue Medical, Inc. |
4590 Patrick Henry Dr. |
Santa Clara,
CA
95054
|
|
Applicant Contact |
Laurent Schaller |
Correspondent |
Musculoskeletal Clinical Regulatory Advisers LLC |
1050 K Street NW, Suite 1000 |
Washington,
DC
20001
|
|
Correspondent Contact |
Justin Eggleton |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 12/20/2018 |
Decision Date | 05/23/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|