The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Lucent 3d Spinal System.
| Device ID | K203254 |
| 510k Number | K203254 |
| Device Name: | Lucent 3D Spinal System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spinal Elements, Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 |
| Contact | Julie Lamothe |
| Correspondent | Julie Lamothe Spinal Elements, Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-04 |
| Decision Date | 2021-03-26 |