The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-c Spinal System, Omega Xp Spinal System.
| Device ID | K210044 |
| 510k Number | K210044 |
| Device Name: | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP 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 |
| Subsequent Product Code | ODP |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-07 |
| Decision Date | 2021-06-30 |