Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K203254 |
Device Name |
Lucent 3D Spinal System |
Applicant |
Spinal Elements, Inc. |
3115 Melrose Dr., Suite 200 |
Carlsbad,
CA
92010
|
|
Applicant Contact |
Julie Lamothe |
Correspondent |
Spinal Elements, Inc. |
3115 Melrose Dr., Suite 200 |
Carlsbad,
CA
92010
|
|
Correspondent Contact |
Julie Lamothe |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/04/2020 |
Decision Date | 03/26/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|